MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 90 CM; CATHETER, FLOW DIRECTED

Model Number IPN000073

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

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.

Manufacturer Narrative

Qn#(b)(4).The reported complaint that the "balloon tip of the catheter is twisted" is not able to be confirmed.A representative device was received for investigation with no damage or abnormalities noted.The balloon inflated as per specifications during the functional investigation.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

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.

• Brand Name: CATH PKGD: WEDGE 6 FR 90 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9889591
• MDR Text Key: 185517619
• Report Number: 3010532612-2020-00101
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902004468
• UDI-Public: 00801902004468
• Combination Product (y/n): N
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: IPN000073
• Device Catalogue Number: AI-07126-J
• Device Lot Number: 16F19F0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1