MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, BALLOON TYPE

Catalog Number UNK_NEU

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Inflammation (1932); Perforation (2001); Transient Ischemic Attack (2109); Vasoconstriction (2126); Embolism/Embolus (4438)

Event Date 04/18/2023

Event Type  Death  

Event Description

The survey was conducted in germany, spain and united states.During 28 days follow-up, inflammation of the puncture site (self-resolving), hematoma and hemorrhage at puncture site that prolonged the patient's hospitalization, symptomatic (post-procedural) vasospasm death, post procedural neurological deficit (including tia, stroke) that could be attributed solely to the use of the system's catheter, infection of the puncture site requiring oral or systemic antibiotics, intraprocedural vessel perforation, intraprocedural embolic episode secondary to use of catheter, symptomatic (post-procedural) vasospasm, intraprocedural embolic episode secondary to use of catheter, symptomatic intraprocedural intracranial hemorrhage secondary to use of catheter was reported.No further information was provided.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

The survey was conducted in germany, spain and united states.During 28 days follow-up, inflammation of the puncture site (self-resolving), hematoma and hemorrhage at puncture site that prolonged the patient's hospitalization, symptomatic (post-procedural) vasospasm - death, post procedural neurological deficit (including tia, stroke) that could be attributed solely to the use of the system's catheter, infection of the puncture site requiring oral or systemic antibiotics, intraprocedural vessel perforation, intraprocedural embolic episode secondary to use of catheter, symptomatic (post-procedural) vasospasm, intraprocedural embolic episode secondary to use of catheter, symptomatic intraprocedural intracranial hemorrhage secondary to use of catheter was reported.No further information was provided.

Manufacturer Narrative

Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to as reported "patient death, patient hematoma, patient vasospasm serious, patient hemorrhage - blood loss with sequelae, patient inflammation, patient tia(transient ischemic attack), patient stroke, patient vessel perforation, patient infection, patient thromboembolic event".

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16907720
• MDR Text Key: 314971492
• Report Number: 3008853977-2023-00017
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• 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; Death