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

Model Number	IPN000072
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the balloon at the end of the catheter was broken, so md could not use it on the patient".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of balloon leak/rupture in use is confirmed.Sample was returned for investigation.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/label was returned.The catheter balloon was found ruptured/torn upon receipt of the 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 cause of the ruptured/torn balloon could not be confidently determined.The injection lumen was successfully aspirated and flushed.Some blood exited.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.Some blood was noted on the guidewire.The guidewire was front loaded through the injection extension luer.No resistance was noted; the guidewire was able to advance through the injection lumen.Some blood was noted on the guidewire.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.
Event or Problem Description
It was reported that "the balloon at the end of the catheter was broken, so md could not use it on the patient".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: 6 FR 110 CM BALLOON WEDGE PRESSURE CATHETER
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 14896496
• Report Number: 3010532612-2022-00242
• Device Sequence Number: 14749845
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 05/31/2021
• Device Model Number: IPN000072
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F20A0044
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown