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

Catalog Number	400SMTSTD0515
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the pancreatic artery using a penumbra smart coil (smart coil).During the procedure, the physician introduced a non-penumbra microcatheter in the target vessel and while attempting to advance the first smart coil in the introducer sheath, resistance was experienced.Therefore, the smart coil was removed.The procedure was successfully completed by placing eight additional smart coils.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 pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath.Coagulated blood was found within the introducer sheath.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present on the proximal and distal ends of the embolization coil.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the proximal and distal ends of the embolization coil.If the smart coil is advanced against resistance, damage such as offset coil winds may occur.During functional testing, resistance was experienced due to coagulated blood found within the introducer sheath.The coagulated blood was cleared, and the smart coil was re-sheathed.Subsequently, the smart coil was advanced out of its introducer sheath and through a demonstration microcatheter without an issue.The non-penumbra microcatheter was not returned for evaluation; therefore, the cause of the resistance was unable to 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.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8798832
• Report Number: 3005168196-2019-01379
• Device Sequence Number: 3258313
• Product Code: HCG
• UDI-Device Identifier: 00814548014647
• UDI-Public: 00814548014647
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 06/18/2019
• Report Date (Section F): 01/01/2005

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: 04/18/2021
• Device Catalogue Number: 400SMTSTD0515
• Device Lot Number: F68972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005