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Model Number N/A
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/21/2022
Event Type  Injury  
Event Description
The user facility reported that after ablation using a 6 fr and 8. 5 fr sheath, the involved radiofocus introducer device was removed. The device was fractured, and a fragment (about 6 cm) was left in the patient. The doctor stated that there was no resistance during the manipulation of removal. The fragment was retrieved successfully with a snare through an 11 fr sheath and the procedure was completed. The patient recovered from minor harm. The event occurred intra-operative.
Manufacturer Narrative
Lot number: requested, unknown. Expiration date: unknown due to unknown lot number. Udi - n/a as this product code is not exported to the us market. Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k): k062858, k082644. Visual inspection of the actual sample found that the sheath tube had been fractured and divided into the distal portion and the main body. The length was confirmed to be about 90 mm and 10 mm respectively. Since the length of a normal product is about 100 mm, it was likely that no portion was missing from the actual sample. Magnifying inspection of the fractured area found an elongation in the distal portion. In the main body, an elongation and a scratch near the elongation were observed. Magnifying inspection of the other areas found a dent at about 27 mm from the distal end, and from this point over about 30 mm had been crushed. From the description of the event, the dent was caused when the distal portion was retrieved with a snare from the patient. The fractured area was inspected with an electron microscope, and the following was found in both the distal portion and the main body. Some part was shaped like stretched and torn-off. The fracture surface was smooth. From the above, it was inferred that a sharp object came into contact with the sheath, causing a scratch, which was subsequently subjected to tensile load and fractured starting from the scratch. Assuming that the sheath was exposed to a sharp object and then to tensile force, the following simulation tests have been conducted in the past. After the sheath was scratched using a scalpel, a tensile load was applied until the sheath tube was fractured. As a result, the followings were observed; i) the sheath was partially stretched and torn-off, ii) the fracture surface was smooth. These conditions were considered similar to those of the actual sample. Since the lot number of the actual sample was unknown, review of the manufacturing history or the complaint record could not be performed. From the investigation results, it was inferred that a sharp object came into contact with the sheath, causing a scratch, which was subsequently subjected to tensile load and fractured starting from the scratch. However, from the condition of the actual sample, the object that might have come into contact with the sheath could not be clarified. Relevant ifu reference: "do not scratch the sheath with needle point, cutting tool, or other edged tools. " terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no. (b)(4).
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Manufacturer (Section D)
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
gina digioia
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
MDR Report Key15266884
MDR Text Key298323911
Report Number9681834-2022-00163
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberRR-A50K10A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/22/2022 Patient Sequence Number: 1
RR-A60K25AK; RR-A72K30AL