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

Catalog Number	400SMTSTD0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2016
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 in the anterior communicating artery using penumbra smart coils (smart coils).During the procedure,the second smart coil was unable to advance out of its introducer sheath and into a non-penumbra microcatheter; therefore this smart coil was not used for the procedure.The procedure was completed using new smart coils and the same non-penumbra microcatheter.The physician maintained continuous flush and used a rotating hemostasis valve.There was no report of an adverse effect on the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The embolization coil was observed to be fully advanced out of the sheath intact with the pusher assembly.The pet lock was stuck inside the introducer sheath friction lock and in an attempt to withdraw the coil from the introducer sheath the pet lock was inadvertently broken by the penumbra investigator.There was no visible damage to the embolization coil.The pusher assembly was inadvertently kinked approximately 15.0 cm from the proximal end by the penumbra investigator.The embolization coil outer diameter (od) was measured and found to be within product specification.Conclusions: evaluation of the smart coil revealed the pet lock was bunched up inside the introducer sheath.The damage noted on the pet lock likely contributed to the inability of the physician to advance the pusher assembly.The cause of the pet bunching could not be determined.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.
Additional Manufacturer Narrative
Please note that the year in section box 2.Date of birth was incorrectly reported on the initial mfr report and is being corrected on this follow-up #2 mfr report.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5936283
• Report Number: 3005168196-2016-01296
• Device Sequence Number: 10850758
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2016

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: Health Professional
• Device Expiration Date: 11/23/2020
• Device Catalogue Number: 400SMTSTD0725
• Device Lot Number: F66674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Initial Date Received by Manufacturer: 08/12/2016
• Supplement Date Received by Manufacturer: Not provided; 10/04/2016
• Initial Report FDA Received Date: 09/08/2016
• Supplement Report FDA Received Date: 10/20/2016; 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: 72 YR
• Patient Weight: 80