MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problems Bent (1059); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that issue occurred during insertion of the intra-aortic balloon (iab) in the patient.The medical doctor had difficulty inserting the catheter into the patient therefore the catheter was taken out.The md found the joint part between the balloon and shaft was bent.It is unclear if the catheter was already bent at the time of opening the kit.As a result, the catheter was removed and replaced by a new one.This event occurred before intra-aortic balloon pump (iabp) device was connected.There was no delay or interruption in therapy.No injury and no medical interventions were required.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of the central lumen "between balloon and shaft was bent" is confirmed.Upon visual inspection, a bend was noted to the central lumen near the proximal end of the balloon/beginning of the outer lumen.Upon inserting a guidewire, it could not advance past the location of the bend.The root cause of the bend is undetermined but a potential cause is a result of customer handling.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 revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that issue occurred during insertion of the intra-aortic balloon (iab) in the patient.The medical doctor had difficulty inserting the catheter into the patient therefore the catheter was taken out.The md found the joint part between the balloon and shaft was bent.It is unclear if the catheter was already bent at the time of opening the kit.As a result, the catheter was removed and replaced by a new one.This event occurred before intra-aortic balloon pump (iabp) device was connected.There was no delay or interruption in therapy.No injury and no medical interventions were required.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7334348
• MDR Text Key: 102227504
• Report Number: 3010532612-2018-00042
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F17F0005
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• 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