MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07124
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the doctor had difficulty deflating the balloon after insertion.The doctor stated that the balloon was pretested before insertion.Under fluoroscopy, it was noted that the balloon did not deflate.The doctor tried different syringes to deflate the balloon, but no change.As a result, the catheter and sheath were removed at the same time, and after removal was noted that the balloon tip was missing.It was reported that the patient was fine.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of balloon would not deflate in use is not able to be confirmed.Upon return, the catheter balloon was noted detached/missing from the distal tip of the catheter and therefore, the functional testing of the balloon could not be performed.The inflation lumen was checked for blockages.No blockage was noted; the inflation lumen was successfully aspirated and flushed.The root cause of the detached/missing balloon is undetermined, but a potential cause is withdrawing the catheter through the sheath during removal.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.Other remarks: please reference the medwatch report that was received mw5090207.
Event or Problem Description
It was reported that the doctor had difficulty deflating the balloon after insertion.The doctor stated that the balloon was pretested before insertion.Under fluoroscopy, it was noted that the balloon did not deflate.The doctor tried different syringes to deflate the balloon, but no change.As a result, the catheter and sheath were removed at the same time, and after removal was noted that the balloon tip was missing.It was reported that the patient was fine.

• Brand Name: CATH PKGD: WEDGE 5 FR 110CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9218364
• Report Number: 3010532612-2019-00376
• Device Sequence Number: 19372586
• Product Code: DSP
• UDI-Device Identifier: 00801902002853
• UDI-Public: 00801902002853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: AI-07124
• Device Lot Number: 16F19G0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1