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

Model Number	IPN000188
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10334872
• Report Number: 3010532612-2020-00201
• Device Sequence Number: 19398043
• Product Code: DQY
• UDI-Device Identifier: 00801902001603
• UDI-Public: 00801902001603
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: IPN000188
• Device Catalogue Number: CP-08803
• Device Lot Number: 14F19G0027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1