|
Model Number N/A |
Device Problems
Difficult to Remove (1528); Stretched (1601); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/07/2023 |
Event Type
malfunction
|
Event Description
|
The user facility reported that when the product was used to advance into the blood vessel, the distal tip of the product was pierced into the lesion part.Therefore, when the product was tried to be removed, there was a removal resistance, and the distal tip of the product got stuck.When the product was pulled more strongly, it was pulled out while being stretched, and could be removed.
|
|
Manufacturer Narrative
|
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3: patient sex: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e1: initial reporter name: requested, unknown the actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Terumo medical products (tmp)(importer) registration no.(b)(4) is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.(b)(4).This reported event was unable to be submitted on (b)(6) 2023 due to a esg server issue, timely filing attempts were documented and have been attached.
|
|
Search Alerts/Recalls
|
|
|