MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C1645
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a pelvic arteriovenous malformation (avm) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed a pc400 coil into the target vessel using another manufacturer''s microcatheter.However, the coil was not framing properly and was therefore, removed from the patient.Upon attempting to redeploy the same pc400 coil, the physician experienced resistance and was unable to advance the coil out of the microcatheter.Therefore, the pc400 coil was removed and the procedure was completed using a new pc400 and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked approximately 141.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The introducer sheath friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pc400 mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the pc400.Further evaluation revealed the pusher assembly was kinked.This damage was likely incidental and may have occurred during packaging for return.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Pc400s are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5732817
• Report Number: 3005168196-2016-00823
• Device Sequence Number: 879396
• Product Code: HCG
• UDI-Device Identifier: 00814548011097
• UDI-Public: 00814548011097
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K120330
• 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,Followup
• Report Date (Section B): 05/19/2016

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: 10/31/2022
• Device Catalogue Number: 4004C1645
• Device Lot Number: F61173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2016
• Supplement Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR