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Model Number M00565020 |
Device Problems
Unsealed Device Packaging (1444); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block h6: imdrf device code a020503 captures the reportable event of seal compromised.
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Event Description
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Note: this report pertains to one of two devices to be used during the same procedure.Refer to manufacturer report # 3005099803-2023-03453 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2023, that two wallflex duodenal stent was to be used to treat a 7 mm duodenal tumor malignant obstruction in the duodenum during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During procedure, it was noted that the inner sterile packaging seal was compromised (the subject of this report).A different size wallflex duodenal stent (the subject of mfr.Report # 3005099803-2023-03453) was opened and the inner packaging seal was also compromised.A non-boston scientific device was used to complete the procedure.There were no patient complications reported as a result of this event.
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Event Description
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Note: this report pertains to one of two devices to be used during the same procedure.Refer to manufacturer report # 3005099803-2023-03452 and 3005099803-2023-03453 for the associated device information.It was reported to boston scientific corporation on june 07, 2023, that two wallflex duodenal stent was to be used to treat a 7 mm duodenal tumor malignant obstruction in the duodenum during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During procedure, it was noted that the inner sterile packaging seal was compromised (the subject of this report).A different size wallflex duodenal stent (the subject of mfr.Report # 3005099803-2023-03453) was opened and the inner packaging seal was also compromised.A non-boston scientific device was used to complete the procedure.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a020503 captures the reportable event of seal compromised.Block h10: a wallflex enteral stent and delivery system were received for analysis; the packaging was not returned.The stent was received fully covered by the outer sheath and undeployed.Visual examination of the returned device found the stainless steel separated, the outer blue sheath was bent in different sections, and the outer clear sheath was also found kinked.No other problems were noted with the stent and delivery system.The investigation concluded that the observed failures of stent undeployed, stainless steel separated, outer blue sheath bent, and outer clear sheath kinked were likely due to factors encountered during the procedure.It may be that handling of the device and/or the technique used by the physician (force applied), limited the performance of the device and contributed to the observed failures.The reported event of packaging seal compromised was not confirmed.Based on the available information, there is not enough information to confirm the reported event of packaging seal compromised as the packaging was not returned with the device; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
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Search Alerts/Recalls
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