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

Catalog Number	400SMTHXSFT0410
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked approximately 121.0 and 136.0 cm from the proximal end.The friction lock was visible halfway across the pusher assembly mid-joint.The inner diameter (id) of the introducer sheath and the outer diameter (od) of the pusher assembly mid-joint were measured within specification.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was unable to advance from its position under the friction lock.After decontamination, the pusher assembly was able to be advanced with some difficulty.Some additional kinks were created by the penumbra investigator during this process.The introducer sheath felt tight on the pusher assembly until the kinks were advanced out of the sheath.The id of the introducer sheath and od of the pusher assembly mid-joint were measured within specification.The root cause of the inability to advance the pusher assembly could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the straight sinus vein using penumbra smart coils (smart coils).During the procedure, the physician successfully placed multiple smart coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance another smart coil within its introducer sheath and, therefore, the smart coil was removed.The physician then tried to advance the smart coil out of its introducer sheath on the back table, however was unable to move the smart coil.The procedure was therefore completed using new smart coils 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: 7545378
• Report Number: 3005168196-2018-01056
• Device Sequence Number: 1187042
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/30/2018

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: Physician
• Device Expiration Date: 08/23/2022
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F78845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 79