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

Model Number IPN000257

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that when the cardiac surgeon tried to implant the intra-aortic balloon (iab), it was noted that the balloon detached from the catheter during insertion.As a result, the iab was replaced.It was later reported that the patient deceased.Dr (b)(6) stated that there were no complications caused by the defected iab.The defected device hadn't been inserted fully inside the patient.

Manufacturer Narrative

(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab: balloon damaged 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 Description

It was reported that when the cardiac surgeon tried to implant the intra-aortic balloon (iab), it was noted that the balloon detached from the catheter during insertion.As a result, the iab was replaced.It was later reported that the patient deceased.Dr latifa hernisa stated that there were no complications caused by the defected iab.The defected device hadn't been inserted fully inside the patient.

Event Description

It was reported that when the cardiac surgeon tried to implant the intra-aortic balloon (iab), it was noted that the balloon detached from the catheter during insertion.As a result, the iab was replaced.It was later reported that the patient deceased.Dr (b)(6) stated that there were no complications caused by the defected iab.The defected device hadn't been inserted fully inside the patient.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab balloon damaged is not confirmed.The returned iabc bladder was fully intact.No problems were noted during the functional testing.The returned catheter passed functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number of the returned sample 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.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10641782
• MDR Text Key: 210261957
• Report Number: 3010532612-2020-00288
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: IPN000257
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F18E0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 50