MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN; CROSPERIO RX PTA BALLOON DILATATION CATHETER

Catalog Number SD-40040

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

The concerned device "shiden" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.014" guidewire (gw)."shiden" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosperio rx" (a rx-type pta balloon dilatation catheter, compatible to 0.014" gw) that is distributed in the us under 510(k) # k152887.The actual device concerned was returned and investigated.The balloon was ruptured transversely and broken at 34 mm from the distal tip.The shaft was elongated and broken, but the distal and the proximal radiopaque markers fixed on the inner shaft remained.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 including the visual test, shaft pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.No nonconformity or abnormality was found in the manufacturing processes according to the dhr.The balloon should have been injured in the circumferential direction by hardened and sharp edge of the lesion, and was ruptured transversely when the balloon was inflated.While retrieving it out of the patient, the bulky portion of the ruptured balloon (because the balloon was not folded as a result of the vertical rupture) was caught at the ostium of the sheath and became unable to pull back further.A further attempt to forcibly pull back the device resulted in torn off of the balloon and the shaft to remain the broken fragment in the patient's vessel.

Event Description

The contralateral approach was performed by inserting a sheath (crossroads mg, goodman corporation) through ipsilateral retrograde puncture from rt.Cfa (right common femoral artery).After the guidewire (command, century medical, inc.) passed through the lesion, shiden 4.0mm x 40mm was passed, and the balloon was inflated at 8 atm (nominal pressure) for the distal of the eia (external iliac artery).Next, the balloon was inflated at 8 atm (nominal pressure) for the calcified lesion of the cia (common iliac artery) , however, the lesion could not be dilated.Therefore, the balloon was inflated at 14 atm (rbp), the balloon was ruptured.When it was pulled out, one-third of the balloon broke and remained in the proximal of dfa (deep femoral artery) under fluoroscopy.The broken fragment could not be pull out by the micro snare, so a surgical operation (cutdown) was performed to remove the fraction of the balloon from the patient.Finally, a stent was placed from the cia to the eia.

• Brand Name: SHIDEN
• Type of Device: CROSPERIO RX PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32 akasaka; minato-ku; tokyo 10760-28 ; JA 1076028
• MDR Report Key: 12419074
• MDR Text Key: 278402619
• Report Number: 3002808904-2021-00008
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: SD-40040
• Device Lot Number: SR021644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2021
• 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: 80 YR