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

Catalog Number IAB-S840C

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on the intra-aortic balloon (iab) "blocked lumen.Guidewire not passing." there was no report of patient death or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of tight over guidewire is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The reported complaint will be monitored for any developing trends.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.No further action required at this time.

Event Description

It was reported on the intra-aortic balloon (iab) "blocked lumen.Guidewire not passing." there was no report of patient death or complications.

Event Description

It was reported on the intra-aortic balloon (iab) "blocked lumen.Guidewire not passing." there was no report of patient death or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of tight over guidewire is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The reported complaint will be monitored for any developing trends.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.No further action required at this time.Other remarks: the complaint was reopened to investigate the device returned to teleflex for investigation.The reported complaint of iab tight over guidewire is confirmed.Multiple kinks and areas of flattening were noted on the iab central lumen during the complaint investigation, and a guidewire could not fully advance through the central lumen.The root cause of how the central lumen became kinked/flattened is undetermined.A potential cause is user handling.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 revised risk.The reported complaint will be monitored for any developing trends.No further action required at this time.

• 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: 7942113
• MDR Text Key: 123806394
• Report Number: 3010532612-2018-00305
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17M0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1