MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN915317
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "iab rupture/abrasion catheter removed".As reported by the clinical support specialist: "emailed received 27dec2022 to report incident on (b)(6) 2022 11:20am.Rt called to confirm blood specs in helium line.Tubing clamped and call placed to [physician].[physician] removed catheter at (b)(6) 2022 at 1:56 pm.Hematoma at groin site.No difficulty noted on removal, no complications.Patient currently critical due to nature of illness and complicated course (not due to iab removal).No iab catheter replaced.No blood noted in pump or condensation tubing, pump sent to biomed for inspection, catheter retained for return.".
Additional Manufacturer Narrative
Qn # (b)(4).The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 30cc 8.0fr fos intra-aortic balloon catheter (iabc) without the original packaging.Upon return, there was damage immediately noted to the flex-tip assembly (part of the iabc central lumen); the flex-tip assembly noted broken at approximately 75.5cm from the iabc luer end.The iabc distal tip was noted within the iabc bladder membrane.The hub of the teflon sheath was noted at approximately 26.7cm from the iabc luer end and was noted connected to the hemostasis cuff.The one-way valve was tethered to the short driveline tubing.The supplied inflation driveline tubing was connected to the short driveline tubing; it was noted that the inflation driveline connector (specifically the connector which connects to the pump) was previously removed from the tubing and was not returned with the sample.Overall, the tubing appeared typical, dried blood was noted within the inflation driveline tubing, and evidence of a previous connector was noted.The iabc bladder was fully unwrapped.Numerous bends to the iabc central lumen were noted at approximately 20.5cm, 40.5cm, 68cm and 71.5cm from the iabc luer end.A kink to the iabc central lumen was noted at approximately 64.3cm from the iabc luer end.Dried blood was noted on the exterior surfaces of the returned iabc.Dried blood was also noted within the helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.No damage or abnormalities were noted to the cal key.The bladder thickness was measured at six points with measurements ranging from 0.0057in-0.0059in.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.The cal key and fos were connected to the iabp.The cal key was recognized.The fos was recognized and zeroed by the iabp.The pump status displayed "ok" indicating the fiber is fully intact.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in the bladder inflation.The results are consistent with the previously noted broken central lumen.The iabc was leak tested.A leak was immediately detected from the distal end of the bladder membrane.Upon cleaning, the distal end of the bladder was noted separated and no longer attached to the iabc distal tip and the distal end of the bladder was noted folded within the iabc bladder.The leak noted from the distal end of the bladder is consistent with the iabc distal tip separation from the iabc bladder.Under microscopic inspection, evidence of previous bond to the iabc distal tip was noted on the distal end of the iabc bladder.The distal end of the bladder was blocked off and the iabc was leak tested again.A leak was immediately detected from the bladder membrane.Under microscopic inspection, multiple abrasions were observed at approximately from 19.8cm to 20.2cm, 20.5cm to 21cm and 21.2cm to 21.7cm from the distal end of the bladder.A full thickness abrasion to the bladder was confirmed at approximately 20cm from the distal end of the bladder and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected.The 0.025in guidewire could not be back loaded into the iabc distal tip due to the returned state of the device (iabc distal tip noted within the bladder membrane).The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 64.2cm from the iabc luer, which is the location of the previously noted kink.Some blood noted on the guidewire.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 risk is acceptable.This will be monitored for any developing trends.The reported complaint of iab blood in helium pathway is confirmed based on visual inspection.Upon return, there were various damages to the central lumen, distal tip and bladder.The intra-aortic balloon catheter (iabc) bladder was also noted with abraded areas, consistent with repeated contact with calcified plaque on the aortic wall.Due to the combined damages and returned state of the device, it could not be co nfidently determined which damage occurred first or what initially caused the complaint.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 blood in the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "iab rupture/abrasion catheter removed".As reported by the clinical support specialist: "emailed received 27dec2022 to report incident on 12/25/22 11:20am.Rt called to confirm blood specs in helium line.Tubing clamped and call placed to [physician].Removed catheter at 12/25/22 at 1:56 pm.Hematoma at groin site.No difficulty noted on removal, no complications.Patient currently critical due to nature of illness and complicated course (not due to iab removal).No iab catheter replaced.No blood noted in pump or condensation tubing, pump sent to biomed for inspection, catheter retained for return.".

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: 16086865
• Report Number: 3010532612-2023-00003
• Device Sequence Number: 2034171
• Product Code: DSP
• UDI-Device Identifier: 10801902161892
• UDI-Public: 10801902161892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: IPN915317
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21K0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 119 KG