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

Model Number	IPN923527
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that "during the procedure according to ifu, balloon at the end of the catheter was broken, so [the clinician] could not use it on the patient" additional information states that the catheter ruptured during use on the patient.An additional catheter was inserted.No report of patient harm or injury.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The report states that "during the procedure according to ifu, balloon at the end of the catheter was broken, so [the clinician] could not use it on the patient" additional information states that the catheter ruptured during use on the patient.An additional catheter was inserted.No report of patient harm or injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states that "during the procedure according to ifu, balloon at the end of the catheter was broken, so [the clinician] could not use it on the patient" additional information states that the catheter ruptured during use on the patient.An additional catheter was inserted.No report of patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The reported lot number (16f22a0058) matches the lot number on the returned original packaging pouch.Returned for investigation was a 6fr.110cm wedge catheter with the original packaging pouch.The sample was returned in the ups shipping box and was in a sealed bio-hazard bag.The sample was loosely packed within the original packaging pouch.Upon return, the inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 1.0cc.The supplied control stroke syringe was not returned with the sample.Upon microscopic inspection, a wrinkle was noted on the balloon surface and small stress marks were visible on the edges of the balloon surface.No contrast media was noted in the injection lumen extension line.No condensation was noted in the inflation lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned catheter.No other visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 1.0cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 5mm.The other side measured approximately 5mm.The inflation lumen was injected with 1.0cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed.Upon tug test, no pull away was noted.The balloon was placed in water, and air was injected into the inflation lumen again.No leak was noted.The injection lumen was aspirated and flushed.No blood or debris was noted.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 (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "balloon at the end of the catheter was broken" is not confirmed.During the investigation, the balloon inflated as per specifications.The returned device passed functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15600756
• Report Number: 3010532612-2022-00426
• Device Sequence Number: 11332220
• Product Code: DYG
• UDI-Device Identifier: 10801902206746
• UDI-Public: 10801902206746
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K892530
• 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,Followup
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22A0058
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 12/06/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/08/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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