MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000261

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the staff advanced the sheath, it began to "fold up on itself. " the staff removed that sheath and placed a 9 fr sheath. When they tried to advance the balloon through the 9 fr sheath, it would not advance due to the balloon "bunching up. " as a result, a second iab was used successfully. There was no report of patient complications, serious injury, or death.

• Brand Name: REDIGUARD IAB: 9FR 50CC
• 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: 12705725
• Report Number: 3010532612-2021-00319
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902010803
• UDI-Public: 00801902010803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: IPN000261
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG