MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK DELIVERY CATHETER; DQY

Catalog Number BMK6F105BER130

Device Problems Air Leak (1008); Fracture (1260); Leak/Splash (1354); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2015

Event Type  malfunction  

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a medical procedure using a benchmark delivery catheter.During the procedure, physician noticed air bubbles leaking at a fracture in the proximal shaft of the benchmark catheter.The benchmark catheter was removed and the physician further damaged it while inspecting the device.There was no report of an adverse effect on the patient.

Manufacturer Narrative

The benchmark delivery catheter (benchmark dc) was fractured in the strain relief approximately 1.0 cm from the hub and ovalized approximately 4.0 cm from the distal tip.The complaint has been evaluated.The complaint indicated that during a procedure, the benchmark dc was found fractured in the proximal shaft near the hub of the catheter.The benchmark dc was damaged further upon examination by the physician after removal from the patient.This type of damage typically occurs due to improper handling during use.If the benchmark dc is manipulated forcefully at an angle during insertion into the patient, the strain relief may fracture due to excess force and bending.The damage found near the distal tip may have occurred during examination by the physician after removal from the patient.These devices are 100% visually inspected for damage during process inspection.

• Brand Name: BENCHMARK DELIVERY CATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4807050
• MDR Text Key: 15253465
• Report Number: 3005168196-2015-00539
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: BMK6F105BER130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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