MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number M0061752630

Device Problem Migration (4003)

Patient Problems Inflammation (1932); Pain (1994); Urinary Incontinence (4572)

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

Report source: study: (b)(6) clinical study.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was to reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.The percuflex plus ureteral stent was implanted on (b)(6) 2022 with no problems reported during placement.On (b)(6) 2022, it was reported that the patient experienced cystitis.On (b)(6) 2022 the patient reported experiencing urine leakage, the patient still presented urine leakage due to the stent displacement.It was found the stent migrated.The percuflex plus ureteral stent was successfully removed from the patient in the operating room.The event was considered resolved.

Manufacturer Narrative

Block g3: study: u0652 double-j registry clinical study.Block h6: medical device problem code of a010402 is being used to capture the reportable issue of stent migration.Block h11: updated block b5: describe event or problem with the additional information received on august 22, 2022.Updated block b6: removed the statement 'the patient has a history of being immunocompromised and osteoporosis.' and moved to block b7 (other relevant history).

Event Description

It was to reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.The percuflex plus ureteral stent was implanted on (b)(6) 2022 with discharge medications included acetaminophen (tylenol) and nsaids.No problems reported during stent placement.On (b)(6) 2022, it was reported that the patient experienced flank pain due to ureteral spasm and had cystitis.Also, the patient presented urine leakage due to the stent displacement.On (b)(6) 2022, it was found that the stent had migrated.The percuflex plus ureteral stent was successfully removed from the patient in the operating room.On (b)(6) 2022 the events of cystitis and flank pain due to the ureteral spasm and urine leakage were considered resolved.Additional information received on august 22, 2022: the percuflex plus ureteral stent was removed early due to urine leakage.In the physician's assessment, action taken urine leakage, updated from none to stent removal alters the medical review.Based upon medical review assessment, the data reasonably suggest the clinical events cystitis, assessed as moderate, not requiring intervention, and flank pain (due to ureteral spasm) assessed as severe, and both events reported as causally related to the device, and not related to the procedure or stent removal, are anticipated in nature and severity.As per dr.Glaser, the flank pain was due to the ureteral spasm.Urine leakage/incontinence, assessed as mild and leading to early stent removal, and reported as causally related to the device and not related to the procedure or stent removal.

Manufacturer Narrative

Block g3: study: u0652 double-j registry clinical study.Block h6: medical device problem code of a010402 is being used to capture the reportable issue of stent migration.Block h11: updated block b5: describe event or problem with the additional information received on october 20, 2022.

Event Description

It was to reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6)2022 as part of the u0652 double-j registry clinical study.The percuflex plus ureteral stent was implanted on (b)(6) 2022 with discharge medications included acetaminophen (tylenol) and nsaids.No problems reported during stent placement.On february 17, 2022, it was reported that the patient experienced flank pain due to ureteral spasm and had cystitis.Also, the patient presented urine leakage due to the stent displacement.On (b)(6) 2022, it was found that the stent had migrated.The percuflex plus ureteral stent was successfully removed from the patient in the operating room.On (b)(6) 2022 the events of cystitis and flank pain due to the ureteral spasm and urine leakage were considered resolved.Additional information received on august 22, 2022: the percuflex plus ureteral stent was removed early due to urine leakage.In the physician's assessment, action taken urine leakage, updated from none to stent removal alters the medical review.Based upon medical review assessment, the data reasonably suggest the clinical events cystitis, assessed as moderate, not requiring intervention, and flank pain (due to ureteral spasm) assessed as severe, and both events reported as causally related to the device, and not related to the procedure or stent removal, are anticipated in nature and severity.As per dr.Glaser, the flank pain was due to the ureteral spasm.Urine leakage/incontinence, assessed as mild and leading to early stent removal, and reported as causally related to the device and not related to the procedure or stent removal.Additional information received on october 27, 2022: on (b)(6) 2022, a ct scan was performed and a stop date of (b)(6) 2022.Based upon medical review assessment, the data reasonably suggest the clinical events cystitis, assessed as mild, and requiring ct scan, and reported to be probably related to the procedure and device, and not related to stent removal, and urine leakage or incontinence, assessed as moderate, and leading to early stent removal, and reported to be probably related to the device and not related to the procedure or stent removal, are anticipated in nature.

• Brand Name: PERCUFLEX PLUS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14455058
• MDR Text Key: 292189260
• Report Number: 3005099803-2022-02534
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924608
• 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: 11/14/2022

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: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0028530310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 08/23/2022; 10/20/2022
• Supplement Dates FDA Received: 09/15/2022; 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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 Age: 64 YR
• Patient Sex: Female