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

Catalog Number IAB-05840-LWS

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion of an intra-aortic balloon (iab) when the medical doctor inserted the guidewire there seemed to be difficulty and the guidewire was "stuck" when trying to feed the balloon over it.The actual balloon was punctured by the guidewire and a new iab was opened and inserted over the same guidewire.The intra-aortic balloon pump alarmed.Blood was noted in the line.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.Patient outcome: patient stable.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint that the bladder membrane was punctured by the guidewire is not able to be confirmed.Although, the root cause of the complaint is undetermined the bladder membrane passed functional and dimensional inspection.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.No further action required.

Event Description

It was reported that during insertion of an intra-aortic balloon (iab) when the medical doctor inserted the guidewire there seemed to be difficulty and the guidewire was "stuck" when trying to feed the balloon over it.The actual balloon was punctured by the guidewire and a new iab was opened and inserted over the same guidewire.The intra-aortic balloon pump alarmed.Blood was noted in the line.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.Patient outcome: patient stable.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6687223
• MDR Text Key: 79073605
• Report Number: 1219856-2017-00145
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S16L0001
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1