MAUDE Adverse Event Report: KANEKA CORPORATION SENRI; SENRI ¿ BALLOON DILATATION CATHETER

Catalog Number BD-S50150L

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

The concerned device "senri" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.018"guidewire (gw)."senri" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosstella rx" (a rx-type pta balloon dilatation catheter, compatible to 0.018" gw) that is distributed in the us under 510(k) # k152873.The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.Results of the investigation on returned concerned device: there is no abnormality at the distal tip and balloon part.The shaft was broken at the base of the balloon 162 mm from the distal tip.The gw lumen was torn between 170 mm to 276 mm from the distal tip.We also confirmed that the gw lumen was broken at 276 mm from the distal tip.The outer shaft and gw lumen were torn to the guide wire port.No nonconformity or abnormality was found in the manufacturing processes according to the device history records (dhr).In addition, actual investigations of the concerned device confirmed the shaft broken, but no cause due to the manufacturing process or design.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Factors that may contribute to the shaft broken include, but are not limited to the following.It is probable that the operator delivered the concerned device from the tip of the sheath until the gw port of the product came out.Therefore, when the concerned device was tried to remove from the sheath, the gw used in combination was slackened at the sheath tip and formed a loop.In that state, the operator further pulled the concerned device, so the gw lumen (gw port) of the product was torn in the distal direction by the gw, and the shaft of the product was broken.

Event Description

After crossover pta, the senri catheter was pulled back but at the 4fr terumo introducer sheath the distal marker with a balloon fragment got torn off.An attempt to retrieve the fragment with a snare catheter fails.The piece is finally fixed in the wall by a stent implantation and the lumen is thus secured.On (b)(6) 2021, due to an acute thrombosis in the stented afs segment, a femoral bypass has to be performed.The balloon fragment will be recovered and preserved.The patient status is unknown.We will contact the hospital/physician to get more information on the status of the patient.(b)(6) 2021 additional information call with dr.(b)(6): he used a radifocus introducer ii in 4fr, an 0.018'' gw advantage wire and the senri balloon during the procedure.After using the balloon, it was not easy to pull back the balloon into the sheath but with "increasing resistance" it was finally possible.Then a section tore off.Dr.(b)(6) pulled the balloon out via a 7f destination, picked up the senri and measured it.According to his calculation (and what he saw), only a small piece of marker was missing.Since he had to stent a right stenosis anyway, he took two overlapping smartflex stents for it, pressing the fragment against the vessel wall.A week after discharge, the patient came back with a cold leg.The surgeons then recovered a piece of senri and gave it to dr.(b)(6).He saved it all and we will pick it up tomorrow.Dr.(b)(6) thinks the balloon would have split longitudinally from the gw advantage wire.The patient received a p1 bypass after the stent thrombosis and was discharged two days ago.

• Brand Name: SENRI
• Type of Device: SENRI ¿ BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 53082 88; JA 5308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi,settsu-city; osaka, 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32; minato-ku, akasaka; tokyo, 10760-28 ; JA 1076028
• MDR Report Key: 13050317
• MDR Text Key: 288273480
• Report Number: 3002808904-2021-00013
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K152873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BD-S50150L
• Device Lot Number: SR091299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male