MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 4 FR 50CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07134
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the event occurred prior to use on a patient (pre-testing).It was reported that the balloon ruptured or perforated before testing.As a result, a new berman angiographic catheter was used.There was no report of patient injury or consequence.It was reported that the ruptured occurred prior to use.The sample was received for investigation.A preliminary investigation was done, dried blood was noted within the injection extension line of the returned sample.The complaint was reassessed and deemed reportable.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of a "problem with the balloon" is confirmed.Upon inflation, a leak was noted near the distal side of the junction hub.Under microscopic inspection, a pinch off/damage to the catheter extrusion was noted near the distal side of the junction hub causing the leak.The root cause of the issue is related to the manufacturing process.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.A non-conformance has been initiated to further investigate the root cause.Other remarks: additional information was received from the assistant chief technologist cardiology.It was confirmed that the berman catheter was inside of the patient when they noted that the balloon would not use/hold the co2 therefore the catheter was removed.The issue was resolved by using another catheter.There were no reported adverse event to the patient.
Event or Problem Description
It was reported that the event occurred prior to use on a patient (pre-testing).It was reported that the balloon ruptured or perforated before testing.As a result, a new berman angiographic catheter was used.There was no report of patient injury or consequence.Additional information.It was reported that the ruptured occurred prior to use.The sample was received for investigation.A preliminary investigation was done, dried blood was noted within the injection extension line of the returned sample.The complaint was reassessed and deemed reportable.

• Brand Name: CATH PKGD: BERMAN 4 FR 50CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8514706
• Report Number: 3010532612-2019-00113
• Device Sequence Number: 19213618
• Product Code: DYG
• UDI-Device Identifier: 00801902002266
• UDI-Public: 00801902002266
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 12/31/2019
• Device Catalogue Number: AI-07134
• Device Lot Number: 16F18H0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1