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

Model Number	IPN923527
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the balloon got ruptured during the inflation test before use.Therefore, a new kit was opened instead".However, upon return of the sample, dried blood was noted on the exterior and interior of the device indicating that it was used on a patient.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "the balloon got ruptured during the inflation test before use.Therefore, a new kit was opened instead".However, upon return of the sample, dried blood was noted on the exterior and interior of the device indicating that it was used on a patient.Be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 05 july 2023 states that "the returned catheter was the correct one.So, the event occurred while in use on a patient." additional information states that the issue was resolved be removing the catheter and inserting a 2nd catheter at the same insertion site.No patient harm or injury.The patient status is reported as "fine".The reported lot number (16f22l0039) matches the lot number on the returned original packaging label and on the teleflex japan label.Returned for investigation was a 6fr.110cm wedge catheter with the original packaging label and the teleflex japan label.The sample was returned in the ups shipping box and was in a sealed ziploc bag.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, the catheter balloon was immediately noted ruptured/torn at approximately 0.2cm to 0.5cm from the distal tip of the catheter.Dried blood was noted in the injection lumen extension line.Dried blood was noted in the inflation lumen extension line.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the interior surfaces of the returned sample.No other damage or abnormalities were noted to the returned sample.The symmetry of the balloon could not be measured due to the returned state of the device.The balloon could not be functionally tested due to the returned state of the device.The balloon damage was previously confirmed near the distal tip of the catheter.The cause of the ruptured/torn balloon cannot be determined.The injection lumen was aspirated and flushed.Dried blood exited.A lab inventory 0.025in guidewire was back loaded through the distal tip of the catheter.No resistance was noted; the guidewire was able to advance through the injection lumen.Some blood was noted on the guidewire.The guidewire was front loaded through the injection lumen extension line luer.No resistance was noted; the guidewire was able to advance through the injection lumen.Some blood was 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 reported complaint of balloon leak/rupture in use is confirmed.The catheter balloon was found ruptured/torn upon receipt of the sample.The cause of the ruptured balloon could not be confidently determined.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 ruptured/torn balloon.The root cause of the complaint 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.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17232181
• Report Number: 3010532612-2023-00312
• Device Sequence Number: 7091096
• Product Code: DYG
• UDI-Device Identifier: 10801902206746
• UDI-Public: 10801902206746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/05/2023

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: 04/30/2024
• Device Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22L0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown