MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STRETCH VL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	M0061851550
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a stretch vl ureteral stent was used during a left ureteroscopic holmium laser lithotripsy and left ureteral stent implantation procedure in the left ureter.The exact procedure date was not reported.On (b)(6) 2020, one month after the stent placement, a stent removal procedure was performed.According to the complainant, during the removal procedure and inside the patient, when the physician attempted to remove the stent, the stent was difficult to remove.The patient was hospitalized because the stent could not be retrieved.The physician performed left ureteroscopy examination under combined spinal epidural anesthesia in emergency.It was found that the pelvis end of the stent was hardened and had secondary stone.The physician used a pair of foreign body forceps to retrieve the stent.The stone on the pelvis end of the stent fell off and the physician was able to straighten and completely remove the stretch vl ureteral stent.Reportedly there was no new stent implanted.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on that the reported removal occurred one month after the stent was implanted, (b)(6), 2019.Block d7: approximated based on that the reported removal occurred one month after the stent was implanted, (b)(6) 2019.Block e1: initial reporter state: (b)(6) block h6: device code 1528 captures the reportable code of stent difficult to remove.Device code 1077 captures the reportable code of stent calcified.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: 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 mdr will be filed.Block h11: correction to field e1: initial reporter phone additional information: b3: date of event, b5: describe event or problem, d6: implant date, d7: explant date, and e1: initial reporter address 1, initial reporter address 2, initial reporter state, initial reporter zip code.
Event or Problem Description
It was reported to boston scientific corporation that a stretch vl ureteral stent was used during a left ureteroscopic holmium laser lithotripsy and left ureteral stent implantation procedure in the left ureter.The exact procedure date was not reported.On (b)(6) 2020, one month after the stent placement, a stent removal procedure was performed.According to the complainant, during the removal procedure and inside the patient, when the physician attempted to remove the stent, the stent was difficult to remove.The patient was hospitalized because the stent could not be retrieved.The physician performed left ureteroscopy examination under combined spinal epidural anesthesia in emergency.It was found that the pelvis end of the stent was hardened and had secondary stone.The physician used a pair of foreign body forceps to retrieve the stent.The stone on the pelvis end of the stent fell off and the physician was able to straighten and completely remove the stretch vl ureteral stent.Reportedly there was no new stent implanted.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.**additional information received on (b)(6) 2020** it was reported that a stretch vl ureteral stent was used during a left ureteroscopic holmium laser lithotripsy and left ureteral stent implantation procedure in the left ureter on (b)(6), 2019.One month after the stent placement, a stent removal procedure was performed.The exact removal procedure date was not reported.

• Brand Name: STRETCH VL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10349858
• Report Number: 3005099803-2020-03031
• Device Sequence Number: 11454886
• Product Code: FAD
• UDI-Device Identifier: 08714729160786
• UDI-Public: 08714729160786
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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 Expiration Date: 07/21/2022
• Device Model Number: M0061851550
• Device Catalogue Number: 185-155
• Device Lot Number: 0024141891
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR