MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07124

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  malfunction  

Event Description

The reprot states, "we had 3 5fr x 110 wedges ( ai- 07124 ) fail, the balloon broke".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Additional information received on 04 august 2023 states that "the first balloon ruptured in the distal pulmonary artery.Just distal to the lpa stent.It is possible that the balloon ruptured on the stent, but the stent struts were well opposed to the vessel wall, so shouldn't have had an interaction with the tips of the stent struts.The second rupture occurred perhaps by over-inflating balloon with a co2 filled syringe.A 2nd attending joined the case and may not have known that it was a 5 fr wedge balloon instead of a 6 fr, which we more commonly use.The 3rd balloon ruptured on the proximal side of the stent in the lpa.Very atypical location for it to rupture." as a result, a 4th catheter was inserted at the same insertion site and was successful.No patient harm or injury.The patient status is reported as "healthy".The reported complaint that the "balloon broke" was not able to be confirmed as the product was not returned for investigation.The additional information received, stated that the "second rupture occurred perhaps by over-inflating balloon with a co2 filled syringe.A 2nd attending joined the case and may not have known that it was a 5 fr wedge balloon instead of a 6 fr, which we more commonly use." this indicated that the user did not follow the instructions for use (ifu) for the balloon inflation.As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states; "warning: do not inflate the latex balloon beyond the stated maximum inflation capacity.Exceeding this volume will not appreciably increase the diameter of the balloon and will increase the possibility of balloon rupture." 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 root cause of the complaint was undetermined.No further action was required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data:.

Event Description

The reprot states, "we had 3 5fr x 110 wedges ( ai- 07124 ) fail, the balloon broke".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: CATH PKGD: WEDGE 5 FR 110CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17409610
• MDR Text Key: 320126345
• Report Number: 3010532612-2023-00430
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902206739
• UDI-Public: 10801902206739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: AI-07124
• Device Lot Number: 16F22H0065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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