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

Catalog Number	4002C3260
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	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the first penumbra coil 400's (pc400) pusher assembly.The pusher assembly was fractured approximately 25.0 cm from the proximal end and kinked in multiple locations throughout its length.The embolization coil was detached from the pusher assembly and not returned for evaluation.The pet lock was intact on the proximal end of the second pc400¿s pusher assembly.The pusher assembly was fractured approximately 29.0 and 62.0 cm from the proximal end and kinked near the fractures.The segment of the pusher assembly distal to the second fracture and the embolization coil were not returned for evaluation.Conclusions: evaluation of the returned pc400's revealed that the pusher assemblies were fractured and kinked, and the embolization coils were detached.Since the pc400's were reportedly removed from the procedure with no mention of fracture or detachment, these damages were likely incidental and may have occurred during packaging for return to penumbra.Since the pc400's were fractured and detached, they could not be functionally tested for advancement through a microcatheter, and the root cause of the reported resistance could not be determined.There was no visible damage to the lantern delivery microcatheter (lantern).A demonstration coil was advanced through the lantern without issue.The other pc400 mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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: 1.3005168196-2017-02176, 2.3005168196-2017-02177.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400's (pc400's).It was noted that the patient's anatomy was mildly tortuous, but no calcification, stenosis or constriction was observed.During the procedure, the physician placed a non-penumbra diagnostic catheter towards the target vessel then advanced a lantern delivery microcatheter (lantern) through the diagnostic catheter.While attempting to advance the first pc400 through the lantern, the physician experienced resistance midway through the lantern and was unable to advance the coil further.Therefore, the pc400 was removed from the lantern and a new pc400 was opened.It was reported that the same issue was encountered with this subsequent pc400 and therefore, the coil was removed from the lantern.After that, the physician successfully deployed and detached a new pc400 into the target vessel using the same lantern.While attempting to advance another pc400 through the lantern, the physician experienced resistance midway through the lantern again and therefore, the pc400 was removed.The lantern was then removed and the procedure was completed using the diagnostic catheter and nine additional coils.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: 7106469
• Report Number: 3005168196-2017-02175
• Device Sequence Number: 16537727
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2017

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: 06/19/2024
• Device Catalogue Number: 4002C3260
• Device Lot Number: F70225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1