MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX96 ACCESS SYSTEM; DQY, QJP

Catalog Number BMX9690BER125

Device Problems Material Puncture/Hole (1504); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Event Description

The patient was undergoing a medical procedure in the left middle cerebral artery (mca) using a bmx96 access system (bmx96), a non-penumbra sheath, a non-penumbra catheter (vtk), and a guidewire.During the procedure, the physician advanced the sheath through the common femoral artery (cfa) to the thoracic aorta.It was reported the patient¿s anatomy was tortuous.Next, a guidewire along with the catheter was advanced to the left carotid artery.The physician then attempted to advance the bmx96 over the catheter; subsequently, a kink and a small hole was noticed on the proximal end of the bmx96.Therefore, the bmx96 was not used for the remainder of the procedure.The procedure was completed using a new bmx96.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned bmx96 confirmed a kink and hole was present on the catheters proximal end.If the device is manipulated against resistance during use, damage such as this may occur.Based on the reported complaint, the patient¿s anatomy was tortuous.This may have contributed to resistance during the procedure.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.

• Brand Name: BENCHMARK BMX96 ACCESS SYSTEM
• Type of Device: DQY, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16834765
• MDR Text Key: 314647546
• Report Number: 3005168196-2023-00205
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 815948022645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: H00001382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• 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
• Patient Age: 68 YR
• Patient Weight: 186 KG