MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 5 FR 80 CM; BERMAN ANGIOGRAPHIC CATHETER PRODUCT

Catalog Number AI-07135

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cath lab.The md stated during insertion of an ai-07135 the contrast agent leaked from the extension line of the inserted catheter when starting injection.As a result, the catheter was removed.A new kit was opened and used without issue.The procedure went on as planned successfully.There was no report of patient death, complications, injury and no medical or surgical intervention was required.It was stated there was no delay or interruption in the procedure.The patient outcome is good.

Manufacturer Narrative

(b)(4).

• Brand Name: CATH PKGD: BERMAN 5 FR 80 CM
• Type of Device: BERMAN ANGIOGRAPHIC CATHETER PRODUCT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth dr; chelmsford MA 01824 000
• Manufacturer Contact: kathryn myers, regulatory associa ; 2400 bernville rd; reading, PA 19605-0000 ; 6103780131
• MDR Report Key: 4479636
• MDR Text Key: 5346103
• Report Number: 3010532612-2015-00004
• Device Sequence Number: 1
• Product Code: DYG
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F14F0014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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