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

Model Number IPN000254

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The report was received from a user facility report (ufr)/medwatch (b)(4).It was reported that blood flecks were noted in the helium line on the balloon pump (approximately 1 hours after arrival from the cath lab).After a few minutes later it was noted blood was pooling into the helium line.As a result, the intra-aortic balloon (iab) and pump were removed.There was no report of patient complications, serious injury or death.Additional information was received from the sales rep that the cath lab manager mentioned there was two iab ruptures since (b)(6) 2019.This is the first iab of the two iab that the sales representative reported had ruptured.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

The report was received from a user facility report (ufr)/medwatch 4900240000-2019-8198.It was reported that blood flecks were noted in the helium line on the balloon pump (approximately 1 hours after arrival from the cath lab).After a few minutes later it was noted blood was pooling into the helium line.As a result, the intra-aortic balloon (iab) and pump were removed.There was no report of patient complications, serious injury or death.Additional information was received from the sales rep that the cath lab manager mentioned there was two iab ruptures since november 2019.This is the first iab of the two iab that the sales representative reported had ruptured.

• 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: 9775485
• MDR Text Key: 184874655
• Report Number: 3010532612-2020-00022
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.