MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation (2001)
Date of Event	11/09/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation), thromboembolic events, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism using an indigo system aspiration catheter 12 (cat12), lightning aspiration tubing (lightning), a non-penumbra sheath (cook flexor 12fr) and a guidewire (amplatz).During the procedure, the physician placed the sheath in the pulmonary artery, then advanced the cat12 through the sheath.The physician connected the lightning to the cat12 and initiated aspiration.During aspiration, the indicator light on the lightning unit turned yellow and the lightning and cat12 appeared to be occluded.The cat12 was removed to be flushed, but no thrombus was found.The lightning was disconnected and cleared.The physician then placed the cat12 back into the patient, and the cat12 occluded again.The cat12 was removed again, and the sheath was noticed to be occluded.Therefore, the sheath was removed and flushed, then placed back into the patient over the guidewire.An image was taken, and the physician discovered a perforation in the pulmonary artery.The procedure ended at this point.The patient was initially stable.Approximately twenty minutes later, the patient became unstable.The patient expired on the same day, and the patient's death was related to the perforation.It is unknown if the cat12 was in the patient at the time the perforation occurred.It is also unknown which device being used caused the perforation.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10972658
• Report Number: 3005168196-2020-02219
• Device Sequence Number: 10958184
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K200771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/08/2020
• 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: Death
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005