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

Model Number	IPN039778
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on the morning of (b)(6) 2022, a [clinician] from the ccu of henan provincial people's hospital, inserted the iab-06830-u catheter for the patient.After the catheter was inserted, [the clinician] found that there was a crack on the aircraft sheath attached to the tail of the catheter, and blood was leaking out along the crack.After many attempts of [compression], the problem was still not solved.The [clinician] planned to pull out the catheter and puncture with sheath.The [clinician] inserted with a new set of iab catheters." additional information states that "it was a sheathless insertion.No defect prior to the insertion.The crack is peel-away hemostasis device".Further information states that an additional catheter was inserted at a second insertion site of the right femoral artery and that there was no harm or injury to the patient.
Event or Problem Description
It was reported that "on the morning of (b)(6) 2022, a [clinician] from the (b)(6) hospital, inserted the iab-06830-u catheter for the patient.After the catheter was inserted, [the clinician] found that there was a crack on the aircraft sheath attached to the tail of the catheter, and blood was leaking out along the crack.After many attempts of [compression], the problem was still not solved.The [clinician] planned to pull out the catheter and puncture with sheath.The [clinician] inserted with a new set of iab catheters." additional information states that "it was a sheathless insertion.No defect prior to the insertion.The crack is peel-away hemostasis device".Further information states that an additional catheter was inserted at a second insertion site of the right femoral artery and that there was no harm or injury to the patient.
Additional Manufacturer Narrative
Qn#(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The reported lot number (18f22f0017) matches the lot number on the returned original packaging box and for the returned sample.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box.The sample was returned in a cardboard box and was loosely packed within the original packaging box and was within a yellow bio-hazard bag.Returned with the sample were semi-finished kit components including 30cc inflation driveline tubing, 60cc luer-slip syringe, short/long arterial pressure tubing and semi-finished insertion kit components including 0.025" guidewire, 8fr teflon sheath w/sidearm, 8fr dilator, 8fr teflon sheath w/dilator assembly and 8fr pre-dilator; no damage or abnormalities were noted to the returned components.Dried blood was noted on the exterior surfaces of the returned components.No damage/crack was noted to the returned short and long arterial pressure tubing luers.Upon return, the one-way valve was connected and tethered to the short driveline tubing.The bladder was fully unwrapped.Numerous bends were noted to the iabc central/outer lumen at the iabc distal tip.A kink to the iabc central lumen was noted at approximately 23.8cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc.No obvious blood was noted within the iabc helium pathway.The returned 8fr teflon sheath w/sidearm was visually inspected.The returned sheath appeared used; dried blood was noted on the "exterior"/interior surfaces of the returned sheath and dried/liquid blood was noted within the sheath sidearm.No visual damage or abnormalities were noted to the returned sheath.The hub and the tip of the returned 8fr teflon sheath w/sidearm appeared typical.The sheath hub cap was removed, and the seal was visually inspected; no damage or abnormalities were noted.Vaseline/petroleum jelly was noted on the seal.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.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 of iab leak suspected is confirmed.During the investigation, the iabc central lumen was noted damaged/broken near the distal tip.The damaged central lumen caused the reported complaint.No damage was noted to either of the returned short and long arterial pressure tubing.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 damaged catheter.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Common Device Name: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15591420
• Report Number: 3010532612-2022-00401
• Device Sequence Number: 19412048
• Product Code: DSP
• UDI-Device Identifier: 10801902145618
• UDI-Public: 10801902145618
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2024
• Device Model Number: IPN039778
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F22F0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown