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.

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.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint for iab balloon unwrapped prematurely is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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: 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
• MDR Text Key: 278613808
• 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: Nurse
• 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: Health Professional
• 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 Sequence Number: 1