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

Catalog Number	AI-07126
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "i have a balloon wedge catheter that ruptured during use".When asked what intervention was chosen the customer states "no intervention required".The patient's current status is reported as "unknown".The customer reported that there was no harm or health consequences to the patient.
Event or Problem Description
It was reported "i have a balloon wedge catheter that ruptured during use".When asked what intervention was chosen the customer states "no intervention required".The patient's current status is reported as "unknown".The customer reported that there was no harm or health consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 6fr.Wedge 110cm catheter with the original packaging pouch.The sample was returned in a cardboard box and was in a ziploc bag.Upon return, the inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 1.0cc.Upon microscopic inspection, the balloon appeared typical; no visual damage or abnormalities were noted to the balloon.No condensation was noted in the inflation lumen extension line.No contrast media was noted in the injection lumen extension line.A few spots of dried blood were noted on the exterior surfaces of the returned catheter.No blood was noted on the interior surfaces of the returned catheter.The control stroke syringe was not returned with the catheter.The inflation lumen was injected with 1.0cc of air using a lab inventory control stroke syringe.The balloon inflated asymmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4.5mm.The balloon did meet specifications per graphic of radius ratio less than or equal to 1.5.The inflation lumen was injected with 1.0cc of air using a lab inventory control stroke syringe.The balloon inflated asymmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.The injection lumen was successfully 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.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 for "balloon wedge catheter that ruptured during use" is not confirmed.During the investigation, no damage or abnormalities were noted to the returned sample and the balloon inflated/ deflated 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: ARROW 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20686145
• Report Number: 3010532612-2024-00960
• Device Sequence Number: 8700621
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: (01)00801902002877(11)240712(17)251231(10)16F24G0027(21)
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F24G0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown