MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW BERMAN ANGIOGRAPHIC BALLOON CATHETER; CATHETER, FLOW DIRECTED

Model Number AI-07135

Device Problems Inflation Problem (1310); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2019

Event Type  malfunction  

Event Description

Prior to inserting the catheter into the body, it was flushed and the balloon was checked by inflating with carbon dioxide.The balloon was not inflating and was sticking when we would attempt to inflate, not allowing a complete inflation of the balloon tip catheter.

• Brand Name: ARROW BERMAN ANGIOGRAPHIC BALLOON CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 16 elizabeth dr; chelmsford MA 01824
• MDR Report Key: 8726819
• MDR Text Key: 148948791
• Report Number: 8726819
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AI-07135
• Device Lot Number: 16F18M0069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1460 DA
• Patient Weight: 17