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

Model Number	RBYPCLP45
Medical Device Problem Codes	Failure to Advance (2524); 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	09/02/2020
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 coil embolization procedure in the gastroduodenal artery (gda) using packing coil lps, ruby coil lps and non-penumbra microcatheter.During the procedure, the physician successfully implanted multiple packing coil lps and ruby coil lps into the target vessel through the microcatheter.The physician then experienced resistance after advancing approximately half of another packing coil lp into the vessel; consequently, the remaining half of the packing coil lp became stuck inside the microcatheter and would not advance further.Therefore, the packing coil lp was removed.The procedure was completed using additional packing coil lps, ruby 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 its pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was intact with its pusher assembly inside its introducer sheath and had offset coil winds.The introducer sheath had coagulated blood inside its lumen.Conclusions: evaluation of the returned packing coil lp revealed offset coil winds on the proximal end of the embolization coil.If the packaging coil lp is forcefully manipulated against resistance, damage such as offset coil winds may occur.During the functional test, the packaging coil lp could not be re-sheathed or advanced out of its introducer sheath due to resistance, and therefore, the device could not be functionally tested.The root cause of resistance during the procedure could not be determined.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.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10601205
• Report Number: 3005168196-2020-01601
• Device Sequence Number: 19737943
• Product Code: HCG
• UDI-Device Identifier: 00815948021945
• UDI-Public: 00815948021945
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/02/2020
• 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: 01/01/2025
• Device Model Number: RBYPCLP45
• Device Catalogue Number: RBYPCLP45
• Device Lot Number: F95273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005