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

Catalog Number IAB-05840-LWS

Device Problem Entrapment of Device (1212)

Patient Problems Injury (2348); Vascular System (Circulation), Impaired (2572)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was difficulty encountered during the removal of the catheter.Vascular surgery was needed to remove the intra-aortic balloon (iab).Once the catheter was removed, granules were seen inside the balloon.The femoral flow was compromised.Medical/surgical intervention was required.There was no reported patient death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of removal difficulty is confirmed.Dried blood was found on the interior of the iab bladder membrane, consistent with contact from the broken fiber near the distal tip of the iab.Although, a definitive root cause of the broken fiber could not be determined.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 has assessed the risk for the reported complaint.There are no new or revised risks.A nonconformance has been initiated to further investigate the root cause.Other remarks: evaluation codes: (b)(4).

Event Description

It was reported that there was difficulty encountered during the removal of the catheter.Vascular surgery was needed to remove the intra-aortic balloon (iab).Once the catheter was removed, granules were seen inside the balloon.The femoral flow was compromised.Medical/surgical intervention was required.There was no reported patient death.

• 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: 6786219
• MDR Text Key: 82447507
• Report Number: 1219856-2017-00191
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0011
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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