MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000254

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that when the patient was transferred the intra-aortic balloon (iab) was noted ruptured.There was no information on the patient.

Event Description

It was reported that when the patient was transferred the intra-aortic balloon (iab) was noted ruptured.There was no information on the patient.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter.Additionally, the iabc central lumen was found broken near the distal tip of the iabc.Both confirmed leaks could result in blood entering the helium pathway; however, it cannot be determined which leak occurred first.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.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10431477
• MDR Text Key: 203720746
• Report Number: 3010532612-2020-00228
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19H0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1