MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; NRY

Catalog Number IAPS3

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

Event Type  malfunction  

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 number: 3005168196-2019-00978.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra engine canister (canister) and an indigo system aspiration catheter 8 (cat8).During the procedure, the penumbra engine (engine) was unable to build vacuum with the canister and, therefore, the physician switched to a new canister.The procedure was then continued, and the physician used a cat8 to aspirate within the patient.After making a pass, the cat8 was removed and flushed on the back table.However, the proximal end of the cat8 was inadvertently kinked while being flushed.The procedure was then completed using a new cat8.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the penumbra engine canister (canister) was undamaged.There was blood present inside the device.Conclusions: evaluation of the returned canister revealed an undamaged, functional device.During functional testing, the canister was seated on a demonstration engine and was able to hold a vacuum pressure within specification.The reported complaint was unable to be confirmed.The indigo system aspiration catheter 8 (cat8) identified in the complaint was not returned for evaluation.Penumbra canisters are 100% visually inspected and functionally tested by the supplier.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 number: 3005168196-2019-00978.

• Brand Name: PENUMBRA ENGINE CANISTER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8615414
• MDR Text Key: 145234580
• Report Number: 3005168196-2019-00977
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019703
• UDI-Public: 00814548019703
• Combination Product (y/n): Y
• PMA/PMN Number: K180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: IAPS3
• Device Lot Number: S10242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR