MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number	PXSLIM045-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	12/11/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using a px slim delivery microcatheter (px slim).During the procedure, the patient experienced a transitory vasospasm in the internal carotid artery.The px slim was exchanged for another manufacturer's microcatheter and the transitory vasospasm was resolved.The transitory vasospasm was adjudicated to have a possible relationship to the px slim, probable relationship to the angiographic procedure and unrelated relationship to the aneurysm disease state.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5439819
• Report Number: 3005168196-2016-00203
• Device Sequence Number: 18979819
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F65255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2016
• Initial Report FDA Received Date: 02/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR