MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545170

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was to be used during a calculus removal procedure performed on (b)(6) 2020.According to the complainant, during unpacking, it was found that there was a "residua" in the contrast agent lumen.Reportedly, there was no damage to the packaging.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6 (device codes): problem code 2944 captures the reportable event of device foreign material present in device.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the device was in good condition and no residue was noted.The reported event was not confirmed.Upon analysis, the device did not present with any visual damage or residue.The visual evaluation showed no evidence of the reported issue or any defect that could have contributed to the reported event.Based on all gathered information, the most probable root cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an autotome rx 44 was to be used during a calculus removal procedure performed on (b)(6) 2020.According to the complainant, during unpacking, it was found that there was a "residua" in the contrast agent lumen.Reportedly, there was no damage to the packaging.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: AUTOTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10717897
• MDR Text Key: 212502187
• Report Number: 3005099803-2020-04843
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444749
• UDI-Public: 08714729444749
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: M00545170
• Device Catalogue Number: 4517
• Device Lot Number: 0024176681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 59