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

Catalog Number	400SMTSFT0203
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the smart coil pusher assembly was kinked approximately 14.0 cm from the proximal end.The pusher assembly was retracted such that the pusher assembly mid-joint was proximal to the pet lock and bent.The pet lock was bunched up around the pusher assembly mid-joint.Conclusions: evaluation of the returned smart coil revealed the pusher assembly had been retracted so that the pusher assembly mid-joint was proximal to the introducer sheath pet lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced upon attempting to advance the coil.Further evaluation revealed bunching of the pet lock.This was likely due to repeated attempts to advance and retract the embolization coil.This bunching likely increased the resistance present at the mid-joint.Upon attempting to advance the embolization coil, the penumbra investigator fractured the pusher assembly.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils).During the procedure, the physician felt resistance and was unable to advance a smart coil out of its introducer sheath and into the non-penumbra microcatheter.It was reported that the smart coil ¿felt stiff¿.The procedure was then completed using a new smart coil.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: 7148285
• Report Number: 3005168196-2017-02319
• Device Sequence Number: 11081381
• Product Code: HCG
• UDI-Device Identifier: 00814548015118
• UDI-Public: 00814548015118
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/01/2017

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: 07/24/2022
• Device Catalogue Number: 400SMTSFT0203
• Device Lot Number: F78343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR