MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number	IPN917225
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the catheter did not work during use.The report state that it was probably a defective valve.
Additional Manufacturer Narrative
(b)(4).The reported lot number 16f22b0093 matches the lot number on the returned packaging.Returned for investigation was a 6fr.Wedge 110cm catheter with its original packaging pouch.The sample was returned in a brown cardboard box and was in a sealed bio-hazard bag.The sample was loosely packed within the original packaging pouch.Upon return, the supplied 1.0cc control stroke syringe was connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position; no visual damage or abnormalities were noted to the stopcock.The recommended volume capacity of the balloon is 1.0cc.No condensation was noted in the inflation lumen.No contrast media was noted within injection lumen.Spots of dried blood was noted on the exterior surfaces of the returned sample.No blood was noted on the interior surfaces of the returned sample.Under microscopic inspection, the balloon appeared typical; however, a crack/damage was noted on the epoxy bond and catheter extrusion beneath the latex balloon near the distal tip; the total length of the crack is approximately 2mm.No other damage or abnormalities were noted to the returned sample.The balloon did not stay inflated during the inflation test due to the cracked catheter extrusion beneath the latex balloon; therefore, the symmetry of the balloon could not be measured.The balloon was injected with 1.0cc of ai r using the returned control stroke syringe.The balloon was fully inflated; however, the balloon started to be deflated within 3 seconds.The balloon was placed in water, and air was injected into the inflation lumen.A leak was apparent from the distal tip of the catheter.The leak is a result of the previously noted cracked distal tip extrusion.The appearance of crack is consistent with damage to the adhesive/epoxy bond and catheter extrusion.No leak was noted from the stopcock.The injection lumen was aspirated and flushed.No blood or debris was noted.Upon further investigation, the distal tip of the catheter was blocked off and air was injected through the injection extension luer, the balloon started inflating.This is consistent with the cracked distal tip extrusion.A lab inventory 0.025in guidewire was back loaded through the distal tip.No resistance was noted; the guidewire was able to advance through the injection lumen.No blood or debris was noted.The guidewire was front loaded through the injection extension line.No resistance was noted; the guidewire was able to advance through the injection lumen.No blood or debris was noted.A device history record review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of catheter leaked in use is confirmed.During the investigation, a leak was noted from the distal ti p of the catheter upon balloon inflation.Under microscopic inspection, a crack to the catheter extrusion and adhesive/epoxy bond was noted at the distal tip of the catheter causing the leak.The crack at the distal tip was the only damage noted.Based on a review of the device history record, the product met specification upon release; however, the received product did not meet specifications during the complaint investigation due to the cracked catheter distal tip.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15537680
• Report Number: 3010532612-2022-00390
• Device Sequence Number: 17641553
• Product Code: DYG
• UDI-Device Identifier: 10801902180312
• UDI-Public: 10801902180312
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 05/31/2023
• Device Model Number: IPN917225
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22B0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; NONE REPORTED.
• Patient Sex: Unknown