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

Model Number	RBYPCLP45
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
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 gastroduodenal artery (gda) using packing coil lps and a non-penumbra microcatheter.During the procedure, the physician implanted four packing coil lps in the target location.While advancing the next packing coil lp through the microcatheter, it became stuck mid-shaft.After removing the packing coil lp, the physician noted that the pusher assembly had become kinked.The procedure was completed using additional packing coil lps 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 pusher assembly.The distal portion of the embolization coil was returned distal to the introducer sheath and had offset coil winds.The embolization coil was intact with the pusher assembly and had offset coil winds at its proximal end.Dried blood was observed within the introducer sheath.Conclusions: evaluation of the returned packing coil lp revealed that the embolization coil had offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the device was unable to advance or retract from the introducer sheath due to the dried blood inside the introducer sheath.The functional testing was unable to be continued; therefore, the root cause of the resistance was unable to be determined.Further evaluation of the device revealed additional offset coil winds on the embolization coil.This damage was likely incidental to the complaint.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: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10556669
• Report Number: 3005168196-2020-01523
• Device Sequence Number: 11473811
• Product Code: HCG
• UDI-Device Identifier: 00815948021945
• UDI-Public: 00815948021945
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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,Followup
• Report Date (Section B): 08/27/2020
• 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: 02/17/2025
• Device Model Number: RBYPCLP45
• Device Catalogue Number: RBYPCLP45
• Device Lot Number: F96346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005