MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® SOLENT¿ PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 109676-001

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 70's.(b)(4).

Event Description

It was reported the tip was torn.An angiojet® solent¿ proxi catheter was selected for use in a thrombectomy procedure in the fistula.During withdrawal from the patient, the catheter tip was noted to be torn.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the solent proxi thrombectomy system.The shaft and tip were microscopically and visually inspected.Blood was present inside the device.There was fluid in the boot.Microscopic and visual inspection revealed that the tip of the device was stretched and completely torn off /separated at the distal window with the jet body detached.The detached tip and jet body were not returned for analysis.The separated ends of the tip were stretched, jagged and damaged; which indicates that the separation was due to tensile overload while withdrawing the device from the patient.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported the tip was torn.An angiojet® solent¿ proxi catheter was selected for use in a thrombectomy procedure in the fistula.During withdrawal from the patient, the catheter tip was noted to be torn.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

• Brand Name: ANGIOJET® SOLENT¿ PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7131107
• MDR Text Key: 95345877
• Report Number: 2134265-2017-12662
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: 109676-001
• Device Catalogue Number: 109676
• Device Lot Number: 21289815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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