MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER; DXE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional 510(k) #¿s that could also apply to this complaint: k161523 and k163618 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, hematoma or hemorrhage at access site, inability to completely remove thrombus, hemorrhage, vessel spasm, thrombosis, dissection, or perforation, peripheral thromboembolic events.Therefore, it was determined that the reported adverse events were anticipated complications.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

Penumbra inc.Became aware on 15-jul-2020 during its post-market surveillance activities of a journal article titled, "aspiration thrombectomy for the management of acute deep venous thrombosis in the setting of venous thoracic outlet syndrome." (teter et al., 2020).It was reported that 16 patients were treated with indigo system aspiration catheter 8 (cat8) or indigo system catrx aspiration catheter (catrx) with optional use of indigo system separator 8 (sep8).All data was gathered from a multicenter retrospective review of procedures taking place in 2017.Among all patients, one patient experienced major bleeding.However, there is no allegation within the article that a malfunction of the indigo system occurred.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.Therefore, this report addresses all adverse events within this literature source.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10393238
• MDR Text Key: 202533287
• Report Number: 3005168196-2020-01168
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/15/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 07/15/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other