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

Catalog Number	4004C0513
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the penumbra coil 400 (pc400) pusher assembly and the pull tube was retracted out of the hypotube.The pusher assembly was kinked approximately 11.0 and 35.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusion; the pc400 was returned without its original introducer sheath.Therefore, a demonstration introducer sheath was loaded onto the pusher assembly, and an attempt was made to re-sheath the embolization coil into the introducer sheath.However, upon retracting the embolization coil into the distal tip of the introducer sheath, the embolization coil became detached.The broken pet lock and retracted pull tube likely contributed to the observed detachment.Since the pc400 introducer sheath was not returned and the pc400 could not be re-sheathed into a demonstration introducer sheath without detachment, the root cause of the resistance reported in the complaint could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a renal artery aneurysm using penumbra coil 400s (pc400s).During the procedure, the physician felt strong resistance while advancing a pc400 more than 10 cm into a non-penumbra microcatheter and therefore, the pc400 was removed.The procedure was completed using the additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: describe event or problem.Report source.Narrative/corrected data.Results: the pet lock was broken on the proximal end of the penumbra coil 400 (pc400) pusher assembly and the pull tube was retracted out of the hypotube.The pusher assembly was kinked approximately 11.0 and 35.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusion; evaluation of the returned device revealed the pet lock was broken and the pull wire was retracted out of the hypotube.A broken pet lock indicates that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the embolization coil.Since there was no mention of detachment attempts in the complaint, the broken pet lock was likely incidental and may have occurred after successful removal of the pc400 from the procedure.The pc400 was returned without its original introducer sheath.Therefore, a demonstration introducer sheath was loaded onto the pusher assembly, and an attempt was made to re-sheath the embolization coil into the introducer sheath.However, upon retracting the embolization coil into the distal tip of the introducer sheath, the embolization coil became detached.The broken pet lock and retracted pull tube likely contributed to the observed detachment.Since the pc400 introducer sheath was not returned and the pc400 could not be re-sheathed into a demonstration introducer sheath without detachment, the root cause of the resistance reported in the complaint could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a renal artery aneurysm using penumbra coil 400s (pc400s).During the procedure, the physician felt strong resistance while advancing a pc400 approximately 10 cm from the tip of a non-penumbra microcatheter and therefore, the pc400 was removed.The procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6966021
• Report Number: 3005168196-2017-01848
• Device Sequence Number: 11029957
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017
• 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: Physician
• Device Expiration Date: 10/22/2024
• Device Catalogue Number: 4004C0513
• Device Lot Number: F72451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005