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

Catalog Number	400SMTXSFT3H06
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 79.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.There were several offset coil winds along the embolization coil¿s length.Conclusions: evaluation of the returned device revealed that the embolization coil windings were offset.If the introducer sheath is not properly seated inside the hub of the microcatheter prior to advancement, the coil may begin to take shape inside the hub.If the device is continually advanced against this resistance, offset coil winds may result.The offset coil windings likely contributed to the difficulty experienced upon advancing the penumbra smart coil (smart coil) into the non-penumbra catheter.The returned smart coil was advanced through a demonstration microcatheter and out of the distal tip without issue.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached a smart coil using a non-penumbra microcatheter.The physician then was unable to advance another smart coil more than 15cm through the microcatheter; therefore, the smart coil was removed.Upon removal, the physician found that the coil and distal tip of the pusher wire of the smart coil had become kinked; therefore, the procedure was completed using additional coils and smart coils.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: 6902839
• Report Number: 3005168196-2017-01648
• Device Sequence Number: 483210
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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: 10/19/2021
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F72375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR