MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000260

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other remarks: see mdr# 3010532612-2020-00037 and (b)(4) as the report is related to the same patient.

Event Description

It was reported that upon insertion of the second intra-aortic balloon (iab), the user was advancing the iab and noted that there was a kinked on the iab.As a result, the iab was removed (partial insertion) and a third attempt was made successfully via the left femoral.There was no report of patient complications or death.

Manufacturer Narrative

Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab kinked is confirmed.Upon visual inspection, the iab central lumen was confirmed with numerous bends and was noted broken near the iab distal tip.No blood was noted inside the iab bladder.The root cause of bent/broken central lumen is undetermined; however, a potential cause of the bent/broken central lumen can be 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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00037 and tc1900074853 as the report is related to the same patient.

Event Description

It was reported that upon insertion of the second intra-aortic balloon (iab), the user was advancing the iab and noted that there was a kinked on the iab.As a result, the iab was removed (partial insertion) and a third attempt was made successfully via the left femoral.There was no report of patient complications or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9666987
• MDR Text Key: 177660398
• Report Number: 3010532612-2020-00036
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• 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: 01/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F18E0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.