MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000253

Device Problem Difficult to Remove (1528)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

Qn (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that an iab was inserted without difficulty.After discontinuation of iabp therapy and the iab was ready for removal, "the doctor couldn't pull negative on the balloon for removal.He tried pulling the balloon back into the catheter and it didn't go easily.He ended up pulling both the sheath and the balloon out but when it was out the balloon was sheared off.He had to hold pressure for about 45 minutes and then after got an ultrasound to make sure nothing was left in the patient.Everything looked ok on the ultrasound and the patient is doing fine." at the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Event Description

It was reported that an iab was inserted without difficulty.After discontinuation of iabp therapy and the iab was ready for removal, "the doctor couldn't pull negative on the balloon for removal.He tried pulling the balloon back into the catheter and it didn't go easily.He ended up pulling both the sheath and the balloon out but when it was out the balloon was sheared off.He had to hold pressure for about 45 minutes and then after got an ultrasound to make sure nothing was left in the patient.Everything looked ok on the ultrasound and the patient is doing fine." at the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

Qn#(b)(4).The reported complaint for iab removal difficulty was not able to be confirmed as the product was not returned for investigation.A device record history review could not be performed as no serial/lot number was reported.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ULTRA 8 IAB: 8FR 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17354961
• MDR Text Key: 319882634
• Report Number: 3010532612-2023-00400
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000253
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2023
• 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
• Patient Age: 73 YR
• Patient Sex: Male