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

Model Number	M0061752620
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific coporation that a previously implanted percuflex plus stent was attempted to be removed from a patient during a procedure in the renal ureter, performed on (b)(6) 2019.On (b)(6) 2019 the patient had a percuflex plus stent implanted without any issues reported.According to the complainant, on (b)(6) 2019, a planned stent removal was performed.During attempted removal, the coil on the kidney side of the stent was kinked near less than 1 cm from the tip.It was unable to be removed normally.The procedure was rescheduled to the next day due to the inability to remove the stent.The following day, the patient underwent an additional stent removal procedure.The physician deliberately cut the coil off of the stent, presumably in order to assist in removal.The stent was removed from the patient using forceps and the procedure was completed.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific coporation that a previously implanted percuflex plus stent was attempted to be removed from a patient during a procedure in the renal ureter, performed on (b)(6) 2019.On (b)(6) 2019 the patient had a percuflex plus stent implanted without any issues reported.According to the complainant, on (b)(6) 2019, a planned stent removal was performed.During attempted removal, the coil on the kidney side of the stent was kinked near less than 1 cm from the tip.It was unable to be removed normally.The procedure was rescheduled to the next day due to the inability to remove the stent.The following day, the patient underwent an additional stent removal procedure.The physician deliberately cut the coil off of the stent, presumably in order to assist in removal.The stent was removed from the patient using forceps and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter address 1: (b)(6).Block f10; h6: problem code and device code 1528 captures the reportable event of stent difficult to remove.Problem code and device code 2976 captures the reportable event of stent kinked upon removal.Block h10: a percuflex plus stent was returned for analysis.A visual evaluation of the reurned device revealed that the stent shaft was detached.Additionally, a kink was observed at the renal pigtail.The proximal section (bladder pigtail) and the suture string were not returned for analysis.The failure found (stent kinked) is an issue that could have been generated by the user or the interaction with other devices and on other hand the stent detached could have been generated by the interacting of the stent with the suture string.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8743394
• Report Number: 3005099803-2019-03325
• Device Sequence Number: 2566223
• Product Code: FAD
• UDI-Device Identifier: 08714729056829
• UDI-Public: 08714729056829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061752620
• Device Catalogue Number: 175-262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR