MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-03 for FORCEP BIO/105/1.8/STR/ ENDOMYOCARDIAL BIOPSY 190070 manufactured by Argon Medical Devices Inc..
[5838446]
Patient was undergoing endomyocardial biopsy via the femoral vein access. During removal of the argon jawz biopsy forceps (1. 8 x 105 cm) while collecting additional biopsy cuttings, the tip end of the introducer sheath ( a fast-cath hemostasis 7f, 98cm made by st. Jude medical) cracked and tightened. This resulted in a perforation of the inferior vena cava with significant bleeding. Patient required a surgical procedure to repair the perforation of the inferior vena cava. As part of the original treatment plan, the patient also received a heart transplant. The patient is in stable condition following the repair of the inferior vena cava, and after receiving the heart transplant.
Patient Sequence No: 1, Text Type: D, B5
[13506754]
A review of the device batch record by lake region medical (contract manufacturer) for the biopsy forceps was performed for raw materials, in-process and finished goods and there were no non-conformances or capas opened for similar complaints. The device met all raw materials, in-process, and finished goods specifications. Per the complainant, st. Jude fast cath introducer 7f x 98 cm was used at the time of the event. This not an argon medical device product; therefore the batch record for this product was not available for review. It was stated by the complainant that there was a crack and tightening of the tip end of the introducer sheath (st. Jude) with the result of perforation of the inferior vena cava. The reported perforation of the inferior vena cava may have been caused by the st. Jude introducer sheath. However, without either device, the root cause of the perforation is not certain. Per the complaint, a sort of resistance (tightening) was experienced at the introducer sheath tip when the biopsy forcep was inserted. This may be an indication of device incompatibility (undersized sheath tip) or an attempt to open the jaws when still inside of the introducer sheath. The ifu states, "the jaws of the biopsy forceps should be opened as the forcep emerges from the distal end of the long sheath introducer or guiding catheter. " there have been no other similar complaints received for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625425-2015-00013 |
| MDR Report Key | 4821449 |
| Report Source | 05 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-04-13 |
| Date Mfgr Received | 2015-05-06 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2015-06-08 |
| 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 | GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK DRIVE |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEP BIO/105/1.8/STR/ ENDOMYOCARDIAL BIOPSY |
| Generic Name | ENDOMYOCARDIAL BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2015-06-03 |
| Catalog Number | 190070 |
| Lot Number | C37887 |
| Device Expiration Date | 2019-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-03 |