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

Model Number	M006175263110
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Initial reporter state: (b)(6).(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 or Problem Description
It was reported to boston scientific corporation on november 20, 2019 that a percuflex plus ureteral stent was used during a unknown procedure performed on unknown date.According to the complainant, during preparation it was noticed that blood adhered on the outer box of the packaging.The sterility of the package was not compromised.The procedure was completed with another percuflex plus ureteral stent.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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2019 that a percuflex plus ureteral stent was used during a unknown procedure performed on unknown date.According to the complainant, during preparation it was noticed that blood adhered on the outer box of the packaging.The sterility of the package was not compromised.The procedure was completed with another percuflex plus ureteral stent.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 Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6)2019 as no event date was reported.Block e1: initial reporter state: (b)(6).Block h6: device code 2969 has been selected to represent the reportable event of foreign matter on the packaging.Block h10: one percuflex plus ureteral stent was returned in its original box un-opened.The box seals were observed in good condition.However, a box label had contamination (foreign matter) confirming the reported complaint.The device history record (dhr) review was performed and no anomalies were observed.During manufacturing process the units are inspected in order to detect or avoid defects as per cosmetic procedure, bsc, ver ae, however, there is no control in how devices are handled in the field; it is possible that the way in which the package was handled and manipulated may have contributed to the failure encountered failure: contamination outside original box.The defect noted may appear due to some aspect of shipping/ handling/ storage of the product, the most probable conclusion code will be documented as cause traced to transport/storage since problems traced to the inappropriate transport or storage of the device.A dhr (device history record) review confirmed that the device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9474533
• Report Number: 3005099803-2019-06018
• Device Sequence Number: 2258616
• Product Code: FAD
• UDI-Device Identifier: 08714729297437
• UDI-Public: 08714729297437
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: M006175263110
• Device Catalogue Number: 175-263-11
• Device Lot Number: 0024367231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1