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

Model Number	RBYPCLP03
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2020
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.This report is associated with mfr report numbers: 3005168196-2020-01938; 3005168196-2020-01940; 3005168196-2020-01941.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils lp and packing coils lp.During the procedure, three ruby coils lp and one packing coil lp would not advance at all within their introducer sheaths and subsequently, the pusher assemblies of two coils kinked.Therefore, the ruby coils lp and packing coil lp were removed.It is unknown which of the two coils out of the four were the ones that the pusher assemblies kinked.The procedure was completed using additional ruby coils lp.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 was kinked approximately 24.5, 62.0 and 138.5 cm from the proximal end.The embolization coil was intact with the pusher assembly, and blood was present inside the introducer sheath.Conclusions: evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.The ruby coil lp was then advanced through its introducer sheath without an issue.Evaluation of the returned packing coil lp revealed a pusher assembly kink near the mid-joint.If the device is advanced against resistance, damage such as this may occur.During functional testing, the packing coil lp was re-sheathed to its initial position within its introducer sheath.The packing coil lp was then advanced through its introducer sheath with resistance due to the pusher assembly kink and the blood within the introducer sheath.The root cause of resistance could not be determined.Evaluation of the second returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was slightly advanced through the introducer sheath friction lock with resistance before additional resistance was experienced due to the pusher assembly kink, and the ruby coil lp could not advance through its introducer sheath.Evaluation of the third returned ruby coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Further evaluation revealed pusher assembly kinks and a fracture near the pusher assembly mid-joint.If the device is forcefully advanced against resistance, damage such as a kink and subsequent fracture may occur.The additional pusher assembly kinks were likely incidental to the reported 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.This report is associated with mfr report numbers: 1.3005168196-2020-01938, 2.3005168196-2020-01940, 3.3005168196-2020-01941.

• Brand Name: PACKING COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10812103
• Report Number: 3005168196-2020-01939
• Device Sequence Number: 4011308
• Product Code: HCG
• UDI-Device Identifier: 00815948021891
• UDI-Public: 00815948021891
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 10/15/2020
• 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: 04/23/2025
• Device Model Number: RBYPCLP03
• Device Catalogue Number: RBYPCLP03
• Device Lot Number: F97508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005