MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000262

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was found leaking during implantation and could not be open.As a result, a new iab was used to complete treatment.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint that the "balloon was found leaking during imp lantation" is not able to be confirmed.The root cause of the complaint 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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon (iab) was found leaking during implantation and could not be open.As a result, a new iab was used to complete treatment.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon (iab) was found leaking during implantation and could not be open.As a result, a new iab was used to complete treatment.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).The reported complaint that the "balloon was found leaking during implantation" is not able to be confirmed.The iab catheter in question was discarded and not available for the investigation.The other insertion components returned for investigation passed specifications.The root cause of the complaint 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 risk.This will be monitored for any developing trends.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11329987
• MDR Text Key: 232003576
• Report Number: 3010532612-2021-00034
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F20A0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR