MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2020-00886, 3005168196-2020-00887.

Event Description

The patient was undergoing a thrombectomy procedure in the posterior cerebral artery (pca) using a penumbra system jet 7 reperfusion catheter (jet7), a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra microcatheter, a non-penumbra sheath and a rotating hemostasis valve (rhv).During the procedure, the physician made a pass using the jet7 and ace68.Upon removal of the jet7 and ace68, the devices became stretched while passing through the rhv.Therefore, the jet7 and ace68 were no longer used in the procedure.A second jet7 was successfully used to make another pass.While retracting the jet7 out of the same rhv, the same issue occurred.It was reported that the rhv was too small; therefore, the rhv and jet7 were no longer used in the procedure.Next, a third jet7 was used with the same microcatheter and a new rhv to successfully complete another pass.Upon removal of the jet7 from the rhv, after successful completion of the procedure, the jet7 stretched and the coil wind came apart.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a thrombectomy procedure in the posterior cerebral artery (pca) using a penumbra system jet 7 reperfusion catheter (jet7), a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra microcatheter, a non-penumbra sheath and a rotating hemostasis valve (rhv).During the procedure, the physician made a pass using the jet7.Upon removal, the jet7 became stretched while passing through the rhv.Therefore, the jet7 was no longer used.Next, while using an ace68 the same issue occurred.Therefore, the ace68 was no longer used.A second jet7 was successfully used to make another pass.While retracting the jet7 out of the same rhv, the same issue occurred.It was reported that the rhv was too small; therefore, the rhv and jet7 were no longer used in the procedure.Next, a third jet7 was used with the same microcatheter and a new rhv to successfully complete another pass.Upon removal of the jet7 from the rhv, after successful completion of the procedure, the jet7 stretched and the coil wind came apart.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-00888.This report is associated with mfr report numbers: 1.3005168196-2020-00886, 2.3005168196-2020-00887.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10228172
• MDR Text Key: 197557781
• Report Number: 3005168196-2020-00888
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• PMA/PMN Number: K173761
• 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: 01/01/2005,06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1