MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565050
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 may 05, 2022 that a wallflex colonic stent was to be used in the colon to treat an intestinal obstruction during stent implantation procedure performed on (b)(6) 2022.During unpacking and outside patient, the physician noticed that the inner sterile packaging was damaged.The device was not used on the patient.The procedure was completed with another wallflex colonic 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 h6: medical device problem code a020503 captures the reportable issue of seal compromised.A wallflex colonic stent and delivery system were received for analysis; the package of the device was not returned.Visual examination of the returned device found the stent was not deployed.The length of the outer clear and blue sheath were measured to be within specification.Microscopic examination revealed the outer clear sheath was kinked.No other issues were noted to the stent and delivery system.The damaged observed to the outer clear sheath were likely due to factors encountered during shipment of the device to the complaint site.It may be how the box was handled or manipulated contributed to the outer clear sheath kinked.Excessive manipulation of the box without enough care could have induced the defect found.The reported event of packaging seal compromised could not be confirmed because packaging of the device was not returned.Due to lack of evidence and without proper evaluation of the packaging, the most probable cause of the reported issue cannot be established.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on may 05, 2022 that a wallflex colonic stent was to be used in the colon to treat an intestinal obstruction during stent implantation procedure performed on (b)(6) 2022.During unpacking and outside patient, the physician noticed that the inner sterile packaging was damaged.The device was not used on the patient.The procedure was completed with another wallflex colonic 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.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 14526714
• Report Number: 3005099803-2022-02900
• Device Sequence Number: 17541471
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0025888446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 69 KG