MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PRO-KINETIC ENERGY US 2.5/18; STENT, CORONARY

Model Number	383882
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The pro-kinetic stent system was chosen for the treatment.Hypotube broke in half after deploying the pro-kinetic energy below knee.A laser was used during procedure.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.The instrument was delivered in a leak-proof and flawless condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.It should be noted that the use of pk energy us is indicated for the implantation in coronary lesions only.

• Brand Name: PRO-KINETIC ENERGY US 2.5/18
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11448513
• Report Number: 1028232-2021-01075
• Device Sequence Number: 4369979
• Product Code: MAF
• UDI-Device Identifier: 07640130435032
• UDI-Public: 07640130435032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 383882
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization