MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number IPN000072

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that when the catheter was in use the staff noted that the balloon would not hold the air and measurement cannot be done.As a result, a new catheter was inserted.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the catheter was in use the staff noted that the balloon would not hold the air and measurement cannot be done.As a result, a new catheter was inserted.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of balloon leak/rupture in use is confirmed.During the investigation, a leak was noted from the distal tip of the catheter upon balloon inflation.Under microscopic inspection, a crack to the catheter extrusion and adhesive/epoxy was noted at the distal tip of the catheter causing the leak.The crack as the distal tip was the only damage noted.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.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.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10482011
• MDR Text Key: 206868778
• Report Number: 3010532612-2020-00252
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: IPN000072
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F19H0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1