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

Model Number IPN000254

Device Problem Unraveled Material (1664)

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

Event Date 09/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the staff tried to advance the sheath, it started to "fold back on itself." the staff was unable to advance the sheath.They removed the sheath and advanced a 9 fr.Sheath.When the staff was advancing the balloon, it appeared to be "unwrapping" since it was bunching up in the sheath, therefore they could not advance the balloon.The blue one-way valve was still in place.As a result, a second iab was used, which worked appropriately.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 of iab unwrapped prematurely 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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported, that when the staff tried to advance the sheath, it started to "fold back on itself".The staff was unable to advance the sheath.They removed the sheath and advanced a 9 fr.Sheath.When the staff was advancing the balloon, it appeared to be "unwrapping", since it was bunching up in the sheath.Therefore they could not advance the balloon.The blue one-way valve was still in place.As a result, a second iab was used, which worked appropriately.There was no report of patient complications, serious injury, or death.

• Brand Name: FIBEROPTIX ULTRA 8 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: 12705644
• MDR Text Key: 278609556
• Report Number: 3010532612-2021-00317
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• 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 Expiration Date: 02/28/2023
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F21C0048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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
• Patient Sex: Male