MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) INTRABEAM NEEDLE APPLICATOR; SYSTEM, THERAPEUTIC, X-RAY

Catalog Number	304534-3001-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Narrative: the manufacturer confirmed that there was no malfunction of the intrabeam system or the intrabeam guiding sleeve.The hcp confirmed that the root cause was applying to much pressure on the guiding sleeve when inserting it into the pedicle and vertebra.The guiding sleeve is not intended to remain in the body and biocompability is tested for 24 hours.The user manual g-30-1723-en, version 8, advises on page 32 "ensure that all components of the "intrabeam needle applicator" set have been completely removed from the body.".Standard external beam radiation therapy is an alternative treatment and can usually be used as follow-up treatment.The hcp made the decision to cement the guiding sleeve in the pedicle like a pedicle screw.
Event or Problem Description
For an intraoperative radiotherapy (iort) during kyphoplasty surgery, the intrabeam system is used together with an intrabeam needle applicator in order to treat interstitial irradiation of tumors.The healthcare professional (hcp) reported that the intrabeam female guiding sleeve, which is a component of the intrabeam needle applicator set, was placed into the pedicle and vertebra with too much pressure causing the sleeve to move completely into the pedicle and vertebra.As a consequence, iort could not be delivered during the planned kyphoplasty surgery with vertebroplasty.The hcp could not remove the penetrated intrabeam female guiding sleeve and he decided to cement the guiding sleeve in the pedicle like a pedicle screw, which was done during the respective standard cementation procedure.The hcp confirmed that the penetration of the guiding sleeve and its cementation did not cause any harm to the patient.The required radiation dose was delivered afterwards via external beam radiotherapy.

• Brand Name: INTRABEAM NEEDLE APPLICATOR
• Common Device Name: SYSTEM, THERAPEUTIC, X-RAY
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• MDR Report Key: 5842177
• Report Number: 9615010-2016-00011
• Device Sequence Number: 773984
• Product Code: JAD
• UDI-Device Identifier: 04049539101372
• UDI-Public: 04049539101372
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K110590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 304534-3001-200
• Device Lot Number: 15295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 08/02/2016
• 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: Other