MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number	IPN000083
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that when the doctor inserted the balloon, it was noted that the balloon would not inflate properly.The catheter was pulled out from the patient's body and inflated, and the balloon burst.Therefore, the doctor judged the product to be defective.As a result, the doctor used a new catheter to complete treatment.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint that the "balloon burst" during use is confirmed.Upon visual inspection, the balloon was found ruptured/torn.During the investigation, a non-teleflex 5ml luer-slip syringe was connected to the inflation lumen.The returned non-teleflex luer-slip syringe barrel is not controlled to prevent the syringe plunger to be pulled more than a desired volume.The maximum capacity of the balloon is 0.75cc and it should not be exceeded.The balloon rupture/damage was a potential result of over-inflation due to the use of a non-control stroke syringe.The root cause of the ruptured balloon is undetermined, but a potential cause is due to over-inflation.An in-service has been requested to reiterate the instructions for use, including the appropriate method for testing balloon integrity before use.The instructions for use state: "do not exceed the maximum inflation capacity of the balloon as indicated on the pigtail of the media injection lumen and in the separate instructions insert.Exceeding this volume will not appreciably increase the diameter of the balloon and will increase the possibility of balloon rupture." and "testing balloon integrity before use: fill the syringe with the amount of inflation medium recommended for the catheter being used.Warning: do not exceed the maximum inflation capacity of the balloon as indicated on the pigtail of the media injection lumen and in the separate instruction insert." 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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that when the doctor inserted the balloon, it was noted that the balloon would not inflate properly.The catheter was pulled out from the patient's body and inflated, and the balloon burst.Therefore, the doctor judged the product to be defective.As a result, the doctor used a new catheter to complete treatment.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10168209
• Report Number: 3010532612-2020-00165
• Device Sequence Number: 2116404
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: 00801902002273
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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: 09/30/2020
• Device Model Number: IPN000083
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F19E0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1