MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000260

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) after two times of normal implantation of the dilator and sheath, when being placed nearly half of the sheath, the catheter could not advance normally.After two times of vacuum evacuation, the catheter was withdrawn horizontally and placed along the spring wire guide (swg).As a result, a new catheter was used to complete the treatment.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

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

Event Description

It was reported that the intra-aortic balloon (iab) after two times of normal implantation of the dilator and sheath, when being placed nearly half of the sheath, the catheter could not advance normally.After two times of vacuum evacuation, the catheter was withdrawn horizontally and placed along the spring wire guide (swg).As a result, a new catheter was used to complete the treatment.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of iab insertion difficulty is not able to be confirmed.Teleflex did not receive the device for investigation.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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 risks.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: the complaint was reopened to investigate the device that was returned to teleflex.The reported complaint of iab insertion difficulty is confirmed.Upon return, the supplied teflon sheath was noted on the iab bladder.During the investigation, the teflon sheath was able to be moved towards the bifurcate without any difficulty; however, the central lumen was found bent near the distal tip of the catheter.A bent central lumen can result in difficulty inserting the iab into the patient.The root cause of the bent central lumen 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 revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) after two times of normal implantation of the dilator and sheath, when being placed nearly half of the sheath, the catheter could not advance normally.After two times of vacuum evacuation, the catheter was withdrawn horizontally and placed along the spring wire guide (swg).As a result, a new catheter was used to complete the treatment.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9135451
• MDR Text Key: 182780517
• Report Number: 3010532612-2019-00346
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F17D0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.; UNKNOWN.