MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX81 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX7F95M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a medical procedure in the m1 segment of the middle cerebral artery (mca) using a benchmark bmx 81 access system (bmx81), a non-penumbra microcatheter, a non-penumbra sheath, a non-penumbra sheath, and a guidewire.During the procedure, it was reported that the physician had difficulty advancing the sheath through the patient¿s tortuous anatomy.Therefore, the sheath was removed.The physician then was able to advance a second sheath to the target location and the bmx81 was advanced through the sheath.Upon completion of the procedure, while retracting the bmx81 from the patient, the physician noticed under fluoroscopy that the cervical portion of the internal carotid artery (ica) was dissected.There was no reported damage to the bmx81.The physician then placed a stent over the dissection.The procedure ended at this point.
Additional Manufacturer Narrative
Evaluation of the returned bmx81 revealed an undamaged and functional device.During evaluation, a test mandrel was advanced through the bmx81 without an issue.Further evaluation revealed bends along the length of the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return to penumbra.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.H3 other text: placeholder.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2023-00300 1.Section h.Box 6.Conclusion code 2.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2023-00300 1.Section h.Box 10.Additional narrative and/or corrected data vessel dissection is included as a possible complication in the ifu for the indigo aspiration system.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event evaluation of the returned bmx81 revealed an undamaged and functional device.During evaluation, a test mandrel was advanced through the bmx81 without an issue.Further evaluation revealed bends along the length of the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return to penumbra.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 h3 other text : placeholder.

• Brand Name: BENCHMARK BMX81 ACCESS SYSTEM
• Common Device Name: 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: 17206436
• Report Number: 3005168196-2023-00300
• Device Sequence Number: 6798359
• Product Code: DQY
• UDI-Device Identifier: 00815948024670
• UDI-Public: 815948024670
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2023
• Device Catalogue Number: BMX7F95M
• Device Lot Number: F00004358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005