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

Model Number IPN000263

Device Problem Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) cannot pass through the introducer sheath.As a result, the iab was replaced, and inserted using the same insertion site.There was no report of patient complications, serious injury, or death.

Manufacturer Narrative

(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of that the "balloon cannot pass through the i introducer sheath" 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 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) cannot pass through the introducer sheath.As a result, the iab was replaced and inserted using the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the "balloon cannot pass through the introducer sheath" is not confirmed.The returned intra-aortic balloon catheter (iabc) had previously been fully advanced through the correct supplied sheath and the sheath moved freely on the catheter during the investigation.No issues were found with the sheath and the iabc.The returned iabc bladder membrane passed dimensional and functional inspection.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.

Event Description

It was reported that the intra-aortic balloon (iab) cannot pass through the introducer sheath.As a result, the iab was replaced and inserted using the same insertion site.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 10854527
• MDR Text Key: 216715871
• Report Number: 3010532612-2020-00367
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F19L0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• 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
• Treatment: NI.; NI.; NI.
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 82 KG