MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number	400SMTXSFT1H03
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the first smart coil revealed an undamaged and functional device.During functional testing, the smart coil was able to advance through its introducer sheath and a demonstration microcatheter without issue.The reported complaint could not be confirmed.Evaluation of the second smart coil revealed kinks along the length of the pusher assembly and offset coil winds along the length of the embolization coil.Based on the complaint, these damages were likely incidental and could have occurred during packaging for return to penumbra.The reported slightly kink on the pusher assembly could not be confirmed.Penumbra coils are visually 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.This report is associated with mfr report number: 3005168196-2020-01242.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right m2 segment of the middle cerebral artery (mca) using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, a smart coil was unable to advance from the starting position within the introducer sheath; therefore, it was removed.The physician then placed multiple smart coils in the target vessel using the same microcatheter.While attempting to advance another smart coil into the microcatheter, the physician noticed the pusher assembly of the smart coil to kinked and, therefore, the smart coil was removed.The procedure was completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10438682
• Report Number: 3005168196-2020-01241
• Device Sequence Number: 17137547
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 00814548015231
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020
• 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 Expiration Date: 07/24/2023
• Device Model Number: 400SMTXSFT1H03
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: F84863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• 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: 07/29/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 89
• Date Report Sent to FDA: 01/01/2005