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

Model Number IPN000263

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was noted to have blood oozing on the black cap of the sheath during puncture, but no cracks were found.When the iab was pushed into the internal body for counterpulsation, cracks were noted on the black cap at the end of the catheter sheath and the amount of bleeding increased.As a result, the catheter and sheath were removed, and a new set was used to complete treatment.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab sheath cracked and leaking is not able to be confirmed.Review of the photo of catheter sheaths submitted with the complaint note a missing sheath cap, however, a photo of the sheath cap was not provided, and all parts included in the customer photo appear normal.The root cause of the complaint is undetermined.If the sample is returned at a later date, a full investigation of the sample will be performed.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.The reported complaint 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) was noted to have blood oozing on the black cap of the sheath during puncture, but no cracks were found.When the iab was pushed into the internal body for counterpulsation, cracks were noted on the black cap at the end of the catheter sheath and the amount of bleeding increased.As a result, the catheter and sheath were removed, and a new set was used to complete treatment.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon (iab) was noted to have blood oozing on the black cap of the sheath during puncture, but no cracks were found.When the iab was pushed into the internal body for counterpulsation, cracks were noted on the black cap at the end of the catheter sheath and the amount of bleeding increased.As a result, the catheter and sheath were removed, and a new set was used to complete treatment.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab sheath cracked and leaking is confirmed.Upon visual inspection, the sheath cap was cracked, which can allow for a blood leak.The cause of the damaged sheath cap was unable to be determined.The remainder of the sheath hub/body was further investigated, and no other damage noted.The root cause of the complaint is undetermined.The complaint is isolated.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.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9652941
• MDR Text Key: 184647866
• Report Number: 3010532612-2020-00014
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F19E0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 67