MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000254

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by that there was "sediment" in the helium driveline that was beige.As a result, the catheter was removed.There was no report of patient complication, serious injury, or death.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint of iab blood in helium pathway is confirmed based on the customer picture provided with the complaint report.The photo showed blood present in the helium pathway.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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported by that there was "sediment" in the helium driveline that was beige.As a result, the catheter was removed.There was no report of patient complication, serious injury, or death.

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 40cc 8.0fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.Upon return, the distal end of the teflon sheath was noted at approximately 27.4cm from the iabc distal tip and the teflon sheath hub was noted connected to the iabc hemostasis cuff.The teflon sheath sidearm was noted cut.The remaining length of the sidearm was not returned with the sample.The iab short driveline tubing was noted cut; the total length of the cut short driveline tubing is 4.0cm.The remaining length of the short driveline tubing including the one-way valve was not returned with the sample.The bladder was fully unwrapped.A kink to the iabc central lumen/teflon sheath extrusion was noted at approximately 42.2cm from the iabc distal tip.Dried green substance was noted on the hemostasis cuff, cathguard and the iabc bifurcate.Dried blood was noted on the exterior surfaces of the returned iabc.Dried blood was also noted within the helium pathway.Additionally, the fos yellow jacket cabling was noted cut; the total length of the cut fos yellow jacket cabling is approximately 4.7cm.The remaining length of the fos yellow jacket cabling including blue fos connector and cal key was not returned with the sample.The customer picture was reviewed.The photo shows some spots of dried blood within the inflation driveline tubing, which is consistent with the reported complaint.The fos connection was unable to be tested due to the cut fos cabling.Upon checking the remaining length of the fos fiber, the fiber was confirmed broken approximately 2.0cm from the iabc distal tip.No other fiber breaks were noted.The iabc central lumen was aspirated and flushed using a syringe.No abnormalities or debris were noted.The iabc was leak tested using.A leak was immediately detected from the bladder membrane.Under microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 2.2cm from the iabc distal tip.No other leaks were detected.A guidewire was back loaded through the iabc distal tip.The guidewire could not advance at approximately 42.3cm from the iabc distal tip, which is the location of the previously noted kink.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 40.6cm from the iabc luer, which is the location of the previously noted kink.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 of iab blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter which allowed blood to enter the helium pathway.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 broken fiber.The root cause of the broken fiber is undetermined.No further action required at this time.This will be monitored for any developing trends.

Event Description

It was reported by that there was "sediment" in the helium driveline that was beige.As a result, the catheter was removed.There was no report of patient complication, serious injury, or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: 12796651
• MDR Text Key: 281518770
• Report Number: 3010532612-2021-00340
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

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 Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21C0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 12/03/2021; 11/09/2022
• Supplement Dates FDA Received: 12/07/2021; 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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: NI.; NI.; NI.