MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 5max ace reperfusion catheter (5max ace) was kinked approximately 57.0 and 59.0 cm from the proximal hub.The 5max ace was fractured approximately 69.0 cm from the hub.The 5max ace was ovalized from 92.0 and 100.0 from the hub.The 5max ace had a slight discoloration at 95.0 cm from its hub.Conclusions: evaluation of the returned 5max ace revealed a long ovalization in the catheter¿s distal region.This damage is likely a result of advancing the 5max ace through a damaged non-penumbra sheath.This ovalization likely contributed to any resistance felt by the physician while positioning the 5max ace.Further evaluation revealed kinks and a fracture on the catheter mid-shaft.These damages are likely a result of continued attempts to advance the 5max ace against resistance.If the catheter continues to be used after it becomes kinked, the damage may become exaggerated and develop into a fracture.Penumbra 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the physician advanced a non-penumbra sheath towards the target vessel and then advanced the 5max ace half way through the sheath.Subsequently, the physician experienced resistance and was unable to advance the 5max ace any further.Therefore, the 5max ace was removed.Next, the physician advanced a non-penumbra balloon catheter towards the ica and then attempted to advance the same 5max ace into the balloon catheter; however, resistance was encountered and the 5max ace would not advance into the balloon catheter.At that point, the proximal shaft of the 5max ace became kinked.Therefore, the 5max ace was removed and the procedure was completed using a non-penumbra stent retriever device.However, the patient was bleeding from the carotid-cavernous sinus fistula (ccf).No medication was given to treat the bleeding.The physician attributed the bleeding to the non-penumbra stent device.There was no report of an adverse effect related to the penumbra device.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6727944
• Report Number: 3005168196-2017-01203
• Device Sequence Number: 16486854
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• 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): 06/20/2017

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: 02/16/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1