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

Catalog Number AI-07124

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

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 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
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: jonathan kimchan ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 9218364
• MDR Text Key: 163196993
• Report Number: 3010532612-2019-00376
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002853
• UDI-Public: 00801902002853
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1