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

Catalog Number AI-07126

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "there was no problem during an inflation test before use.However, when the user inflated the balloon several times in the patient body after insertion of the catheter, the balloon got ruptured.The user removed the catheter and finished the procedure.No injury to the patient was reported.According to the user, the balloon might possibly have been damaged by being caught at the suture when inserting the catheter." the rupture occurred after "a few minutes".The catheter was not replaced.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4), the reported lot number (16f22l0063) matches the lot number on the returned original packaging lid-stock/label.Returned for investigation was a 6fr 110cm wedge catheter with the original packaging lidstock.The sample was returned in the ups shipping box and was in a sealed ziploc bag.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 1.0cc.Upon microscopic inspection, the balloon appeared typical; no visual damage or abnormalities were noted to the balloon.No condensation was noted within the inflation lumen extension line.Some spots of dried contrast media were noted within the injection lumen extension line.No blood was noted on the interior or the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the catheter body.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 5mm.The other side measured approximately 5mm.The balloon did meet specifications per graphic i-07126-007e re.00 of radius ratio less than or equal to 1.5.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification i-07126-007e rev.00.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 returned 0.025in guidewire was back loaded through 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.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 got ruptured" is not confirmed.Upon return, the balloon was fully intact.During the investigation, no leak was noted from the returned sample/balloon.The balloon inflated as per specifications.The returned device passed visual and 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.Corrected data: section d.4.-lot# corrected to 16f22l0063.Section d.4.-expiration date corrected to 30-apr-2024.

Event Description

It was reported that "there was no problem during an inflation test before use.However, when the user inflated the balloon several times in the patient body after insertion of the catheter, the balloon got ruptured.The user removed the catheter and finished the procedure.No injury to the patient was reported.According to the user, the balloon might possibly have been damaged by being caught at the suture when inserting the catheter." the rupture occurred after "a few minutes".The catheter was not replaced.The patient status is reported as "fine".

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: 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: 17515380
• MDR Text Key: 321109872
• Report Number: 3010532612-2023-00434
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902180312
• UDI-Public: 10801902180312
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22L0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1