MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-01-06 for CRYOVALVE SG - PULMONARY HEMI-ARTERY SG SGPH00 manufactured by Cryolife, Inc..
[19726414]
According to the report, the cryolife representative received a call from the complainant informing him of a tissue failure. It was explained to the representative that they began to thaw the hemi tissue. While the tissue remained in the warm bath, they noticed there was a tear in the tissue. They completed the thawing process and removed the tissue from the warm water. The tear was visible through all three layers of the protective plastic pouches. They then informed the surgeon of the tear and the procedure was put on hold for 40 minutes while the complainant went back to (b)(6) to retrieve a second hemi-artery. The second tissue was thawed successfully and implanted into the patient with no complications.
Patient Sequence No: 1, Text Type: D, B5
[19792508]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[22998215]
According to the report, the cryolife representative received a call from the complainant informing him of a tissue failure. It was explained to the representative that they began to thaw the hemi tissue. While the tissue remained in the warm bath, they noticed there was a tear in the tissue. They completed the thawing process and removed the tissue from the warm water. The tear was visible through all three layers of the protective plastic pouches. They then informed the surgeon of the tear and the procedure was put on hold for 40 minutes while the complainant went back to (b)(6) center to retrieve a second hemi-artery. The second tissue was thawed successfully and implanted into the patient with no complications. The complainant also told the rep that he received the tissue without its protective cardboard container. The tissue was wrapped in two paper operating room towels and placed in a cryoshipper. The tissue was not returned to cryolife; therefore, no direct observations could be made. Processing records were reviewed and it was determined that the tissue met all specifications. No deficiencies were noted and there were no incident reports filed in the courier database during the transit/delivery of this package. Investigation revealed that the allograft was shipped to (b)(6) hospital on 12/24/2013 and then transported to a third party, (b)(6) center, where it is unknown how the allograft was handled and stored. When methodist hospital had the need to use the allograft in a procedure six days later on (b)(6) 2013, it was transported to the hospital again under unknown handling and storage conditions. The claim that the allograft was "without its protective cardboard container... Wrapped in two paper operating room towels and placed in a cryoshipper" likely was a result of mishandling of the allograft while at (b)(6) center.
Patient Sequence No: 1, Text Type: N, H10
[22998216]
According to the report, the cryolife representative received a call from the complainant informing him of a tissue failure. It was explained to the representative that they began to thaw the hemi tissue. While the tissue remained in the warm bath, they noticed there was a tear in the tissue. They completed the thawing process and removed the tissue from the warm water. The tear was visible through all three layers of the protective plastic pouches. They then informed the surgeon of the tear and the procedure was put on hold for 40 minutes while the complainant went back to (b)(6) center to retrieve a second hemi-artery. The second tissue was thawed successfully and implanted into the patient with no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00002 |
| MDR Report Key | 3553437 |
| Report Source | 06,07 |
| Date Received | 2014-01-06 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-30 |
| Date Mfgr Received | 2013-12-30 |
| Date Added to Maude | 2014-01-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOVALVE SG - PULMONARY HEMI-ARTERY SG |
| Generic Name | HEART ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-01-06 |
| Model Number | SGPH00 |
| Device Expiration Date | 2018-02-12 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-06 |