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 Consequences Or Impact To Patient (2199)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the intra-aortic balloon (iab) was inserted into the patient and after 10 minutes it was noted that the balloon ruptured in the patient.As a result, the iab and sheath was removed and a new iab and sheath was used, using the same insertion site.There was no report of patient complications, serious injury or death.

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 which allowed blood to enter the helium pathway.The root cause of the broken fiber 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 the intra-aortic balloon (iab) was inserted into the patient and after 10 minutes it was noted that the balloon ruptured in the patient.As a result, the iab and sheath was removed and a new iab and sheath was used, using the same insertion site.There was no report of patient complications, serious injury or death.

• 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: 10453602
• MDR Text Key: 204359717
• Report Number: 3010532612-2020-00238
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20C0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1