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

Model Number	M00570730
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on july 25, 2022 that a wallflex biliary rx partially covered stent was to be implanted to treat a less than 60mm benign stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the wallflex biliary stent was deployed; however, it was noted that the retrieval loop of the wallflex biliary stent was bent.The wallflex biliary stent was removed from the patient with rat-tooth forceps and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: a photo of the complaint device deployed inside the patient was provided by the complainant and showed the retrieval loop of the wallflex biliary stent was bent.
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the wallflex biliary stent was disposed and will not be returned for evaluation; therefore, a device analysis of could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: blocks b5 and h6 (device codes) have been corrected.
Event or Problem Description
It was reported to boston scientific corporation on july 25, 2022 that a wallflex biliary rx partially covered stent was to be implanted to treat a less than 60mm benign stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the wallflex biliary stent was deployed; however, it was noted that the retrieval loop of the wallflex biliary stent was bent.The wallflex biliary stent was removed from the patient with rat-tooth forceps and another wallflex biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: a photo of the complaint device deployed inside the patient was provided by the complainant and showed the retrieval loop of the wallflex biliary stent was bent.Update based on review on september 02, 2022 note: it was reported that the wallflex biliary rx partially covered stent was to be implanted to treat a benign stricture.Per the ifu, "the wallflex biliary rx partially covered stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery".The stent is not indicated for the treatment of benign stricture.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15214750
• Report Number: 3005099803-2022-04492
• Device Sequence Number: 17551220
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 03/03/2024
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0028984516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female