MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number M0067001210

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020, as no exact date was reported.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf impact codes f1001 capture the reportable event of absence of treatment.

Event Description

It was reported to boston scientific corporation that a patient underwent a percutaneous nephrolithotomy procedure in (b)(6) 2020 using a percutaneous access needle.The patient experienced unable to gain access and required case terminated.

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in september 2020.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.Block h11: correction: block h10 (additional mfr narrative).

Event Description

It was reported to boston scientific corporation that a patient underwent a percutaneous nephrolithotomy procedure in september 2020 using a percutaneous access needle.The patient experienced unable to gain access and required case terminated.Additional information received on march 20, 2023: it was clarified that the device had unsuccessful percutaneous access into the renal collecting system despite several attempts.Therefore, the stone removal case was terminated.

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in september 2020.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on april 25, 2023.Block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.

Event Description

It was reported to boston scientific corporation that a patient underwent a percutaneous nephrolithotomy procedure in (b)(6)2020 using a percutaneous access needle.The patient experienced unable to gain access and required case terminated.Additional information received on (b)(6), 2023: it was clarified that the device had unsuccessful percutaneous access into the renal collecting system despite several attempts.Therefore, the stone removal case was terminated.Additional information received on (b)(6), 2023: it was clarified that the inability to gain access was due to the patient's anatomy and not related to the percutaneous access needle.

• Brand Name: INTRODUCER NEEDLES
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16335639
• MDR Text Key: 309292523
• Report Number: 3005099803-2023-00634
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729077749
• UDI-Public: 08714729077749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0067001210
• Device Catalogue Number: 700-121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/20/2023; 04/25/2023
• Supplement Dates FDA Received: 04/17/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White