MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Model Number	3MAXC-B
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01965.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery using a penumbra system jet7 reperfusion catheter (jet7), a penumbra system 3max reperfusion catheter (3maxc), a neuron max 6f 088 long sheath (neuron max) and a guidewire.During the procedure, the physician experienced resistance while advancing a 3maxc to the target location using a jet7 and guidewire.Therefore, the physician decided to remove the 3maxc.While removing the 3maxc from the jet7, it was noticed that a long metal spiral was coming out.Subsequently, the physician removed the whole system.The procedure was completed using a new 3maxc, a new jet7 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 3maxc revealed that the support coil winds were wrapped around the catheter shaft.The coils winds may have come from the reported jet7.There was no visible damage to the 3maxc.If the 3maxc is retracted out of the jet7 after the catheter become fractured, damage such as this may occur.Based on the returned condition of the devices, the root cause of the reported complaint could not be determined.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report number: 3005168196-2021-01965.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12425028
• Report Number: 3005168196-2021-01966
• Device Sequence Number: 3942433
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 00814548019956
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3MAXC-B
• Device Catalogue Number: 3MAXC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 72
• Date Report Sent to FDA: 01/01/2005