MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000257

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported that "during implantation, the catheter could not insert completely.After pulling out the catheter, it was found that the catheter tip was bent, and then a set of iab-06830-u was replaced, it is very smoothly".No patient injury, harm, or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The reported complaint of iab kinked is confirmed.The sample was returned for investigation.No serial number was reported.The serial number on the returned sample is (b)(6).The reported lot number matches the lot number for the returned sample.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.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample were the supplied 8fr dilator and 8fr teflon sheath/dilator assembly; no blood was noted within any components and no abnormalities were noted to the returned components.Also returned were two 0.025in guidewires; the returned guidewires appeared typical during inspection.Upon return, a 0.025in guidewire was noted partially inserted within the iabc central lumen.The one-way valve was connected and tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the iabc central lumen was noted at approximately 23.1cm from the distal tip.Spots of dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.The guidewire returned within the iabc central lumen was removed within minimal force; the guidewire was noted with a bend.The diameter of each returned guidewire measured 0.024" and met specifications per graphic.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute and then 30 seconds five separate times in accordance with internal quality system document.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris was noted.The iabc was leak tested in accordance with testing methods from internal manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.The returned 0.025in guidewire (the guidewire returned without any bends) was back loaded through the iabc distal tip.Resistance was noted at approximately 23.1cm from the iabc distal tip, which is the location of the previously noted bend.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.Resistance was noted at approximately 54.1cm from the iabc luer, which is the location of the previously noted bend.The guidewire was able to advance through the central lumen.No blood or debris was noted.The damaged iabc can result in difficulty inserting the iabc into the patient.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 bend on the central lumen.The root cause of the bend is undetermined.A most probable potential cause is customer handling.No further action required at this time.This will be monitored for any developing trends.

Event Description

It was reported that "during implantation, the catheter could not insert completely.After pulling out the catheter, it was found that the catheter tip was bent, and then a set of iab-06830-u was replaced, it is very smoothly".No patient injury, harm, or consequence reported.Patient condition reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15266831
• MDR Text Key: 304966253
• Report Number: 3010532612-2022-00318
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/28/2024
• Device Model Number: IPN000257
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22C0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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
• Treatment: NONE REPORTED; NONE REPORTED