MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Model Number IPN000188

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after expanding and deflating the balloon, the balloon was stuck inside the arrow 8f short sheath.As a result, the sheath with the stuck balloon was removed as a whole, leaving the guide wire in and inserting another sheath and a new balloon was used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of catheter tight in sheath is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 after expanding and deflating the balloon, the balloon was stuck inside the arrow 8f short sheath.As a result, the sheath with the stuck balloon was removed as a whole, leaving the guide wire in and inserting another sheath and a new balloon was used.There was no report of patient complications, serious injury or death.

• Brand Name: CATH-LAB SHEATH INTRO SET
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10334872
• MDR Text Key: 201997079
• Report Number: 3010532612-2020-00201
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902001603
• UDI-Public: 00801902001603
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000188
• Device Catalogue Number: CP-08803
• Device Lot Number: 14F19G0027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1