MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000257

Device Problem Failure to Advance (2524)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the staff inserted the sheath according to the procedure.When the intra-aortic balloon (iab) was inserted the staff felt resistance when advancing the balloon and could not be inserted.As a result, the iab was replaced and the new iab was able to enter smoothly.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the staff inserted the sheath according to the procedure.When the intra-aortic balloon (iab) was inserted the staff felt resistance when advancing the balloon and could not be inserted.As a result, the iab was replaced and the new iab was able to enter smoothly.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of iab insertion difficulty 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.

Manufacturer Narrative

Qn# (b)(4).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with an original packaging box that does not match the serial number on the returned sample.Returned with the sample were the supplied 30cc inflation driveline tubing, 60cc luer slip syringe, and red luer end cap; no blood was noted within the tubing and no abnormalities were noted to the returned components.Also returned was an unopened semi-finished insertion kit; the kit and its contents appeared typical.Upon return, the original packaging tray was immediately noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.The arrow sticker was noted cut/ripped and a portion of the sticker was completely missing.This packaging sticker is not to be removed.Upon return, the one-way valve was connected and tethered to the short driveline tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.Since damage to the "arrow" packaging sticker was noted, which indicates a potential that the catheter was not prepped per the instructions for use (ifu), an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert supplied syringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal".The bladder thickness was measured at six points.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated numerous times with similar results.Upon further inspection, the one-way valve body was noted damaged; a crack was noted on the one-way valve body.The total length of the crack is 1cm.The one-way valve immediately lost pressure due to the crack.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.A guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.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.The reported complaint for iab insertion difficulty is confirmed.During functional testing, the one-way valve failed, and a crack was noted as the cause on the one-way valve.A failing one-way valve could cause in difficulty prepping the device and result in insertion difficulty.The returned iab catheter passed functional testing.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker, which indicates a potential that the catheter was not prepped per the instructions for use (ifu) and can result in damage to the catheter.As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the crack on the one-way valve.The root cause of the complaint is undetermined.The complaint finding is considered isolated.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the staff inserted the sheath according to the procedure.When the intra-aortic balloon (iab) was inserted the staff felt resistance when advancing the balloon and could not be inserted.As a result, the iab was replaced and the new iab was able to enter smoothly.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: bryanna connelly ; 3015 carrington mill blvd; morrisville, MA 27560
• MDR Report Key: 11147209
• MDR Text Key: 226030297
• Report Number: 3010532612-2020-00404
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN000257
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F20D0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• 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: 94 YR
• Patient Sex: Female
• Patient Weight: 41 KG