MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-26 for AMPLATZ TYPE RENAL DILATOR M0062601200 260-120 manufactured by Boston Scientific Corporation.
[19282247]
It was reported to boston scientific corporation that a renal dilator was inspected upon receipt at the user facility. According to the complainant, during unpacking, "it was found that three devices were damaged". It does not appear to have occurred in shipping, but rather is packaging and/or packing of the devices. This report is for one of three devices. Refer to associated manufacture reports #3005099803-2009-05025 and #3005099803-2009-05027 for a description of the first and third devices. There was no patient involvement in this event. Follow up with the materials coordinator revealed that during an inventory cycle count, it was found that the packages were damaged and sterility was compromised. The packages are stored in a hanging position at the user facility.
Patient Sequence No: 1, Text Type: D, B5
[19340805]
Visual evaluation of the returned device revealed the package to have a jagged tear through it. The tear is most likely due to the pouch coming into contact with another object causing the pouch to be torn. The issue most likely occurred during shipping, storage or handling prior to preparation. Therefore, the most probable root cause is handling damage. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-05026 |
| MDR Report Key | 1516209 |
| Report Source | 05,06 |
| Date Received | 2009-10-26 |
| Date of Report | 2009-09-28 |
| Date of Event | 2009-09-28 |
| Date Mfgr Received | 2009-09-28 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2010-04-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DR. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZ TYPE RENAL DILATOR |
| Product Code | GCC |
| Date Received | 2009-10-26 |
| Returned To Mfg | 2009-10-06 |
| Model Number | M0062601200 |
| Catalog Number | 260-120 |
| Lot Number | 12839473 |
| Device Expiration Date | 2013-08-06 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-26 |