MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC NBCA LIQUID EMBOLIC KIT; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The catalog and lot number are not available; therefore, the manufacture and expiration dates are not available.The product and lot numbers are not available; therefore, udi is unknown.(b)(4).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.This is 1 of 4 mdrs submitted for this complaint with associated report numbers of 1226348-2017-00194, 1226348-2017-00193, 1226348-2017-00192 and 1226348-2017-00191.

Event Description

As reported by a physician, when injecting glue with tantalum and aprox 1/2 cc to 1cc of oil, the glue was not visible as injecting under fluro.Product included trufill nbca 1 gram kit (631500/ ha2573 x 2, 631500/ hf2890 x 1, and unknown catalog/lot x 1).The embolization procedure was for treatment of vein of galin on a (b)(6) infant.The physician, who has been successfully been using nbca glue for many years, added the entire packet of tantalum powder with oil (approx.½ cc to 1cc of oil) to the nbca glue in a glass beaker.The radiopacity of the mixture was not confirmed via flouro prior to injection by comparing the glue to a similar syringe containing contrast as instructed in the ifu.Four separate injections were used and they appeared very faint via flouro, and in one case, the tantalum appeared to be beaded.It was reported that the oil had been protected from light and the mixture was prepared as per the instructions for use (ifu).Fortunately, the patient was successfully treated with no injury.

Manufacturer Narrative

Four glass beakers, one syringe and four plastic containers were received inside of a plastic bag, they were inspected and they were found with residues of powder and dry glue.The rest of the components were not returned for evaluation.The four glass beakers, syringe and the four plastic containers were inspected under microscope and residues of powder gray/glue dried can be observed inside of them.An x-ray was performed on received syringe and the 4 beakers.Residues of the mix of the nbca can be observed.The dhr review of the manufacturing documentation associated with this lot ha2573 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The expiration date for the subassembly components ethiodized oil ha3957 and tantalum powder 16lu604a were reviewed and no anomalies were noted on them.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Information received on 2/28/2018 confirmed that procedure images could not be obtained.As reported by a physician, when injecting glue with tantalum and approximately 1/2 cc to 1cc of oil, the glue was not visible as injecting under fluoroscopy.Product included trufill nbca 1 gram kit (631500/ ha2573 x 2, 631500/ hf2890 x 1, and unknown catalog/lot x 1).The embolization procedure was for treatment of vein of galin on a (b)(6) infant.The physician, who has been successfully been using nbca glue for many years, added the entire packet of tantalum powder with oil (approx.½ cc to 1cc of oil) to the nbca glue in a glass beaker.The radiopacity of the mixture was not confirmed via fluoro prior to injection by comparing the glue to a similar syringe containing contrast as instructed in the ifu.Four separate injections were used and they appeared very faint via fluoro, and in one case, the tantalum appeared to be beaded.It was reported that the oil had been protected from light and the mixture was prepared as per the instructions for use (ifu).Fortunately, the patient was successfully treated with no injury.Multiple attempts to obtain procedure films to confirm the event were unsuccessful.Four glass beakers, one syringe and four plastic containers were received inside of a plastic bag, they were inspected and were found with residues of powder and dry glue.The rest of the components were not returned for evaluation.The four glass beakers, syringe and the four plastic containers were inspected under microscope and residues of powder gray/glue dried coul be observed inside of them.An x-ray was performed on the received syringe and the 4 beakers.Residues of the mix of the nbca could be observed.The dhr review could not be performed since the lot number was not provided.The nbca lack of radiopacity could not be confirmed since during x-ray of the returned materials, residues of the nbca mixture were radiopaque.Additional testing to confirm adherence to specification for the same lot of nbca glue was completed, and the material met all specifications.The cause of the event could not be conclusively determined.The instructions for use warns: ¿prior to injection it is essential to determine, via fluoroscopy, the radiopacity of the mixture by comparison with a similar syringe containing contrast.Inadequate visualization of the mixture could cause inappropriate embolization.¿ a complaint handling database review found no other similar issues for the past 3 years.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is 1 of 4 mdrs submitted for this complaint with associated report numbers of 1226348-2017-00194, 1226348-2017-00192 and 1226348-2017-00191.

• Brand Name: NBCA LIQUID EMBOLIC KIT
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: joaquin kurz ; 325 paramount dr; raynham, MA 02767 ; 9497899383
• MDR Report Key: 7035037
• MDR Text Key: 92909457
• Report Number: 1226348-2017-00193
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA