MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for CATH PKGD: WEDGE 6 FR 90 CM IPN000073 AI-07126-J manufactured by Arrow International Inc..
[185517619]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185517620]
It was reported that "the balloon tip of the catheter is twisted. The device is placed at the jugularis and used for ballooning of the vessel for dogs (veterinary use). When the balloon tip is twisted it is very difficult to move the catheter in the vessel causing a delay resulting in an extension of the anesthesia. " there was no report of harm or complications to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010532612-2020-00101 |
| MDR Report Key | 9889591 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-06-24 |
| Date Added to Maude | 2020-03-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CARMEN SHERMAN |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9782505100 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATH PKGD: WEDGE 6 FR 90 CM |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-03-27 |
| Model Number | IPN000073 |
| Catalog Number | AI-07126-J |
| Lot Number | 16F19F0100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |