MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 60CM; CATHETER, FLOW DIRECTED

Model Number IPN000069

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that staff was unable to advance the wire through the end.As a result, a new catheter was used.No information was able to be obtained regarding the patient.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "unable to advance wire through the end" is confirmed.During the investigation, the distal opening of the injection lumen was found blocked by epoxy.During functional testing, the guidewire was unable to be advance through the distal tip of the catheter due to the blocked distal opening.The root cause is manufacturing related.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.A non-conformance has been initiated to further investigate the issue.

Event Description

It was reported that staff was unable to advance the wire through the end.As a result, a new catheter was used.No information was able to be obtained regarding the patient.

• Brand Name: CATH PKGD: WEDGE 5 FR 60CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10784774
• MDR Text Key: 214544989
• Report Number: 3010532612-2020-00327
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002846
• UDI-Public: 00801902002846
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: IPN000069
• Device Catalogue Number: AI-07123
• Device Lot Number: 16F19K0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1