MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 4 FR 60CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07121
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "when the user was inserting the balloon catheter into a guiding catheter, the balloon was stuck in a guiding catheter.Therefore, the balloon catheter was removed and replaced with a new one to complete the procedure without problem.No injury to the patient occurred".
Additional Manufacturer Narrative
Qn#(b)(4).Returned for investigation was a 4fr 60cm wedge catheter with the original packaging pouch.Upon return, the supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.60cc.Under microscopic inspection, a wrinkle was noted on the balloon.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 exterior surfaces of the returned sample.No other visual damage or abnormalities were noted to the returned.The inflation lumen was injected with 0.60cc of air using the returned control stroke syringe.The balloon inflated asymmetrically.One side of the balloon measured approximately 2mm.The other side measured approximately 5mm.The balloon did not meet specifications of radius ratio less than or equal to 2.0.The outer diameter of the catheter body measured 0.052" and met specifications.The outer diameter of the catheter body at the location of the epoxy (near the distal end of the balloon) measured 0.0595" and did not meet specifications.The outer diameter of the catheter body at the location of the epoxy (near the proximal end of the balloon) measured 0.058" and did not meet specifications the inflation lumen was injected with 0.60cc of air using the returned 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 aspirated and flushed.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 was stuck in a guiding catheter" is confirmed.During the investigation, the outer diameter of the returned sample at the location of the epoxy (proximal and distal ends of the balloon) was noted as out of specification during dimensional inspection.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 excess epoxy.The probable root cause of the complaint is manufacturing related.A non-conformance has been initiated to further investigate the issue.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "when the user was inserting the balloon catheter into a guiding catheter, the balloon was stuck in a guiding catheter.Therefore, the balloon catheter was removed and replaced with a new one to complete the procedure without problem.No injury to the patient occurred".

• Brand Name: CATH PKGD: WEDGE 4 FR 60CM
• 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: 18897171
• Report Number: 3010532612-2024-00206
• Device Sequence Number: 12300301
• Product Code: DYG
• UDI-Device Identifier: 00801902002822
• UDI-Public: 00801902002822
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: AI-07121
• Device Lot Number: 16F23G0048
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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