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

Model Number	IPN923527
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure according to ifu, md found inflation failure.So md opened up the new kit to finish the procedure." there was no delay in therapy.The patient status is reported as "fine".Per the customer, it is unknown if the balloon was tested prior to insertion.
Additional Manufacturer Narrative
Qn#(b)(4).
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
It was reported that "during the procedure according to ifu, md found inflation failure.So md opened up the new kit to finish the procedure." there was no delay in therapy.The patient status is reported as "fine".Per the customer, it is unknown if the balloon was tested prior to insertion.
Additional Manufacturer Narrative
(b)(4).No lot number was reported.The lot number of the returned device is unknown.Returned for investigation was a 6fr.110cm wedge catheter without the original packaging pouch.Upon return, the inflation lumen stopcock was in the open position.The supplied control stroke syringe was not returned with the sample.The recommended volume capacity of the balloon is 1.0cc.Upon microscopic inspection, the catheter balloon was immediately noted ruptured/torn; the balloon was ruptured/torn at approximately 0.3cm from the distal tip of the catheter.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 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 could not be confidently determined.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.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The risk is acceptable.The reported complaint of "inflation failure" is confirmed.The catheter balloon was found ruptured/torn upon receipt of the sample.The cause of the ruptured/torn 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.
Event or Problem Description
It was reported that "during the procedure according to ifu, md found inflation failure.So md opened up the new kit to finish the procedure." there was no delay in therapy.The patient status is reported as "fine".Per the customer, it is unknown if the balloon was tested prior to insertion.

• 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: 16600491
• Report Number: 3010532612-2023-00184
• Device Sequence Number: 12589231
• 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): 03/05/2023

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 Model Number: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: UNKNOWN
• 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: 03/05/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 05/02/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/24/2023; 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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