A1: patient identifier: requested, not provided.A2: age or date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: n/a.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D2: product code: dqo, kra.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).
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The user facility reported that the involved product was passed through a narrowed calcified blood vessel.Thereafter, when trying to remove the product, there was resistance, and the catheter stretched.Though there was resistance the product was eventually removed.
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