MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 5 FR 110CM; BALLOON WEDGE PRESSURE CATHETER PRODUCTS

Catalog Number AI-07124

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2013

Event Type  malfunction  

Event Description

It was reported via a call from the material manager/heart center that the event occurred while in the cath lab.During the case the m.D.Inserted an ai-07124 via radial and it was found that the catheter leaked; pin holes in the balloon were reported.As a result, the catheter was removed successfully.A new ai-07124 was inserted via the same insertion site and the procedure went on as planned successfully.There was no report of patient death, complications or injury.No medical/surgical intervention was required.There was a slight delay or interruption in therapy while the new kit was opened with no harm to the patient noted.The patient outcome is fine.

Manufacturer Narrative

(b)(4).

• Brand Name: CATH PKGD: WEDGE 5 FR 110CM
• Type of Device: BALLOON WEDGE PRESSURE CATHETER PRODUCTS
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth dr; chelmsford MA 01824
• Manufacturer Contact: kathryn myers ; 2400 bernville rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4080546
• MDR Text Key: 20863293
• Report Number: 3010532612-2014-00005
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07124
• Device Lot Number: MF3064280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• 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